核准疫苗及檢驗試劑清單
衛生福利部已核准專案輸入/製造之COVID-19疫苗
The COVID-19 vaccines granted emergency use authorization by Ministry of Health and Welfare (MOHW), Taiwan
| 序號 No. |
中/英文品名 Vaccine name |
核准日期 Approval date |
|---|---|---|
| 1 | 阿斯特捷利康COVID-19疫苗 AstraZeneca COVID-19 Vaccine (Vaxzevria) | 2021/02/20 |
| 2 | 莫德納 COVID-19 疫苗 Moderna COVID-19 Vaccine (Spikevax) | 2021/04/22 |
| 3 | 高端新冠肺炎疫苗 MVC COVID-19 Vaccine | 2021/07/30 |
| 4 | BNT162b2 COVID-19疫苗 BNT162b2 COVID-19 Vaccine | 2021/08/03 |
| 5 | Novavax COVID-19 疫苗 (Novavax) | 2022/06/22 |
上述疫苗相關中文說明書，請參考本部食品藥物管理署官網https://www.fda.gov.tw/TC/siteList.aspx?sid=11845。
For the Chinese instructions of the above vaccines, please refer to the official website of Taiwan Food and Drug Administration：http://www.fda.gov.tw/TC/siteList.aspx?sid=11845。
專案製造新冠病毒檢驗試劑相關產品資訊清單
The domestic COVID-19 IVD granted emergency use authorization by Ministry of Health and Welfare (MOHW), Taiwan
| 序號 No. |
核准日期 Approval date |
試劑名稱 Commercial Name |
製造商名稱 Manufacturer |
檢驗類型 Target |
|---|---|---|---|---|
| 1 | 2020/4/30 | 瑞基新型冠狀病毒 (orf 1ab)檢測試劑 POCKIT Central SARS-CoV-2 (orf 1ab) Premix Kit 瑞基自動化核酸分析儀 POCKIT Central Nucleic Acid Analyzer 瑞基萃取耗材組 POCKIT Central Cartridge Set (B) 瑞基新型冠狀病毒(orf 1ab)檢測試劑陽性對照組 POCKIT Central SARS-CoV-2 (orf 1ab) P(+) Control Reagent |
瑞基海洋生物科技股份有限公司 GeneReach Biotechnology Corporation |
核酸檢測 Nucleic acid |
| 2 | 2020/5/11 | 列特博新型冠狀病毒RNA檢測試劑組 LabTurbo AIO COVID-19 RNA Testing Kit 列特博AIO核酸萃取試劑組 LabTurbo Viral DNA/RNA AIO extraction Kit 列特博AIO全自動核酸偵測系統 LabTurbo AIO SP-qPCR Automation System |
諾貝爾生物有限公司 Taigen Bioscience Corporation |
核酸檢測 Nucleic acid |
| 3 | 2020/5/25 | "高端"新型冠狀病毒核酸檢驗組 MVC SARS-CoV-2 qPCR Kit |
高端疫苗生物製劑股份有限公司委託台塑生醫科技股份有限公司（宜蘭廠）製造 Manufactured by (FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION) for (MEDIGEN VACCINE BIOLOGICS CORPORATION) | 核酸檢測 Nucleic acid |
| 4 | 2020/5/29 | 凌越新型冠狀病毒抗體快速檢測試劑 ALERT SARS-CoV-2 Antibody Rapid Test |
凌越生醫股份有限公司台北廠 EXCELSIOR BIO-SYSTEM INCORPORATION Taipei Factory |
抗體檢測 Antibody |
| 5 | 2020/6/10 | 普生新冠肺炎核酸檢測試劑盒 GB SARS-CoV-2 Real-time RT-PCR |
普生股份有限公司 GENERAL BIOLOGICALS CORP. |
核酸檢測 Nucleic acid |
| 6 | 2020/6/30 | 金萬林SARS-CoV-2核酸檢測試劑套組第一代 KimForest SARS-CoV-2 Detection Kit v1 |
金萬林企業股份有限公司委託世基生物醫學股份有限公司台北廠製造 Manufactured by Pharmigene Inc. for KimForest Enterprise Co., Ltd. |
核酸檢測 Nucleic acid |
| 7 | 2020/7/1 | 泉沂醫學新冠病毒核酸檢測試劑組 GENEONE COVID-19 Nucleic Acid Diagnostic Kit |
泉沂醫學科技股份有限公司 GeneOne Diagnostics Corporation |
核酸檢測 Nucleic acid |
| 8 | 2020/7/1 | "克雷多微特"新型冠狀病毒-19檢驗試劑 VitaPCR SARS-CoV-2 Assay "克雷多微特" PCR分析儀 VitaPCR Instrument "克雷多微特"新型冠狀病毒-19品管套組 VitaPCR SARS-CoV-2 External Control Set |
泉創生醫有限公司 TRENTRON BIOMEDICAL LTD. |
核酸檢測 Nucleic acid |
| 9 | 2020/7/6 | SARS-CoV-2 iPMx分子快速檢驗系統-SARS-CoV-2 試劑套組 SARS-CoV-2 Reagent Kit SARS-CoV-2 iPMx分子快速檢驗系統-SARS-CoV-2 品管物套組 SARS-CoV-2 Control Kit SARS-CoV-2 iPMx分子快速檢驗系統-SARS-CoV-2 iPMx檢測儀 SARS-CoV-2 iPMx Molecular Rapid Test System |
工業技術研究院醫療器材GMP工廠 Industrial Technology Research Institute, Medical Device GMP Manufacturer |
核酸檢測 Nucleic acid |
| 10 | 2020/7/24 | 昕創生醫新型冠狀病毒核酸檢測套組 Innocreate SARS-CoV-2 QD Kit |
昕創生醫技術股份有限公司 Innocreate Bioscience Co., Ltd. |
核酸檢測 Nucleic acid |
| 11 | 2020/7/24 | 德必碁新型冠狀病毒核酸檢驗組 ExProbe SARS-CoV-2 Testing Kit |
德必碁生物科技股份有限公司 TBG BIOTECHNOLOGY CORP. |
核酸檢測 Nucleic acid |
| 12 | 2020/7/27 | 新型冠狀病毒抗體快篩試劑 COVID-19 Antibody Rapid Test |
鼎群科技股份有限公司 TRISON TECHNOLOGY INTEGRATION CORPORATION |
抗體檢測 Antibody |
| 13 | 2020/8/12 | 長興COVIDual COVID-19 抗體檢測試劑 COVIDual COVID-19 antibody Rapid Test |
長興材料工業股份有限公司 ETERNAL MATERIALS CO., LTD. |
抗體檢測 Antibody |
| 14 | 2020/8/20 2022/2/23 |
博錸新型冠狀病毒核酸檢測試劑 IntelliPlex SARS-CoV-2 Detection Kit |
博錸生技股份有限公司 PLEXBIO CO., LTD. |
核酸檢測 Nucleic acid |
| 15 | 2020/8/24 | 東耀新型冠狀病毒抗體快速檢驗試劑 ASK COVID-19 Antibody Rapid Test |
東耀生物科技有限公司 TONYAR BIOTECH. INC. |
抗體檢測 Antibody |
| 16 | 2020/8/27 | 飛確 新型冠狀病毒抗原快速檢驗試劑 Vstrip COVID-19 Antigen Rapid Test |
寶齡富錦生技股份有限公司汐止廠 Panion & BF Biotech Inc. Xizhi Factory |
抗原檢測 Antigen |
| 17 | 2020/9/1 | COVID19 IgG & IgM 快篩檢測試劑 COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) For in vitro diagnosis |
百歐生命科技股份有限公司委託龍騰生技股份有限公司新市廠製造 Manufactured by LOMG TERM BIORESEARCH INC. for AllBio Science, Inc. |
抗體檢測 Antibody |
| 18 | 2020/9/16 | 普生新冠肺炎核酸檢測試劑盒 GB SARS-CoV-2 Real-time RT-PCR 普生病毒核酸萃取試劑 GB SimPrep Viral DNA/RNA Extraction Kit |
普生股份有限公司 GENERAL BIOLOGICALS CORP. |
核酸檢測 Nucleic acid |
| 19 | 2020/11/13 | 列特博新型冠狀病毒RNA檢測試劑組 LabTurbo AIO COVID-19 RNA Testing Kit |
諾貝爾生物有限公司二廠 Taigen Bioscience Corporation Second Factory |
核酸檢測 Nucleic acid |
| 20 | 2020/11/13 | 威創新型冠狀病毒抗原快速檢驗試劑 VTRUST COVID-19 (SARS-CoV-2)Antigent Rapid Test |
泰博科技股份有限公司五股廠 Taibo Technology Co., Ltd. Wugu Factory |
抗原檢測 Antigen |
| 21 | 2020/11/23 | 奎克數位PCR新型冠狀病毒核酸檢驗組 DigiChip SARS-CoV-2 Assay Kit 奎克基因檢測分析儀 Q Station |
奎克生技光電股份有限公司 QUARK BIOSCIENCES TAIWAN, INC. |
核酸檢測 Nucleic acid |
| 22 | 2020/12/2 | 達基 SARS-CoV-2檢測試劑盒 Dagene G SARS-CoV-2 Test Assay 達基核酸萃取試劑盒 Dagene GS1 Nucleic Acid Extraction Kit 達基全自動核酸分析儀 Dagene G1 Automated Nucleic Acid Analysis System |
達爾生技股份有限公司委託日祥生命科學股份有限公司製造 Manufactured by ISTAT BIOMEDICAL CO., LTD. for DELBIO, INC. 達爾生技股份有限公司委託日祥生命科學股份有限公司製造 Manufactured by ISTAT BIOMEDICAL CO., LTD. for DELBIO, INC. 達爾生技股份有限公司委託致茂電子股份有限公司林口廠製造 Manufactured by CHROMA ATE INC. LINKOU PLANT for DELBIO, INC. |
核酸檢測 Nucleic acid |
| 23 | 2020/12/14 | 泓佑新型冠狀病毒抗體快速篩檢試劑組 ACE COVID-19 Antibody Rapid Detection Kit |
泓佑生物科技有限公司委託瑞智生化科技股份有限公司製造 Manufactured by (SWISCARE TECHNOLOGY CO., LTD.) for (ACE BIOLABS CO., LTD.) |
抗體檢測 Antibody |
| 24 | 2020/12/22 | 福又達新型冠狀病毒多重螢光核酸檢驗試劑組 SBC SARS-CoV-2 MDx qPCR Kit |
福又達生物科技股份有限公司委託台塑生醫科技股份有限公司製造 Manufactured by FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION for SCHWEITZER BIOTECH COMPANY LTD. |
核酸檢測 Nucleic acid |
| 25 | 2020/12/30 | 麥博森新冠病毒定溫核酸檢測試劑組 MobioSense COVID-19 Isothermal Nucleic Acid Diagnostic Kit |
麥博森股份有限公司委託泉沂醫學科技股份有限公司製造 Manufactured by GeneOne Diagnostics Co., Ltd. for MobioSense Corp. |
核酸檢測 Nucleic acid |
| 26 | 2021/1/5 | 達基 新型冠狀病毒核酸檢測試劑盒 Dagene M SARS-CoV-2 Assay |
達爾生技股份有限公司委託日祥生命科學股份有限公司製造 Manufactured by (ISTAT BIOMEDICAL CO., LTD.) for (DELBIO INC.) |
核酸檢測 Nucleic acid |
| 27 | 2021/1/11 | 普生新冠肺炎抗體檢測試劑 GB SARS-CoV-2 Ab ELISA |
普生股份有限公司 GENERAL BIOLOGICALS CORP. |
抗體檢測 Antibody |
| 28 | 2021/1/12 | 台塑生醫迅知新型冠狀病毒抗原快速檢驗試劑 Formosa One Sure SARS-CoV-2 Ag Rapid Test Kit |
台塑生醫科技股份有限公司宜蘭廠 FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION Yilan Plant |
抗原檢測 Antigen |
| 29 | 2021/1/12 | 瑞基新型冠狀病毒檢測試劑 POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent 瑞基萃取耗材組 POCKIT Central Cartridge Set (B) |
瑞基海洋生物科技股份有限公司 GeneReach Biotechnology Corporation | 核酸檢測 Nucleic acid |
| 30 | 2021/1/21 | 普生新冠肺炎核酸檢測試劑盒 GBC SimPrep SARS-CoV-2 RT-PCR |
普生股份有限公司 GENERAL BIOLOGICALS CORP. |
核酸檢測 Nucleic acid |
| 31 | 2021/1/28 | “亞諾法” 新型冠狀病毒抗原快速檢驗試劑 “Abnova” COVID-19 Viral Antigen Rapid Test |
亞諾法生技股份有限公司委託龍騰生技股份有限公司新市廠製造 Manufactured by Long Term Bioresearch Inc. Xinshi Factory for Abnova (Taiwan) Corporation |
抗原檢測 Antigen |
| 32 | 2021/2/4 | 三鈺新型冠狀病毒抗原快篩檢測試劑 TRICAN COVID-19 Antigen Rapid Test Kit |
三鈺生物科技股份有限公司委託鼎群科技股份有限公司製造 Manufactured by (TRISON TECHNOLOGY INTEGRATION CORPORATION) for (TRICAN BIOTECHNOLOGY CO., LTD.) |
抗原檢測 Antigen |
| 33 | 2021/2/17 | 福又達新冠肺炎IgG抗體檢測試劑組 SBC COVID-19 IgG ELISA Kit |
福又達生物科技股份有限公司委託精專生醫股份有限公司製造 Manufactured by SCHWEITZER BIOTECH COMPANY LTD. for ACCUBIOMED CO., LTD. |
抗體檢測 Antibody |
| 34 | 2021/3/5 | 台塑生醫新冠病毒抗體酵素免疫檢驗試劑 MeDiPro SARS-CoV-2 Antibody ELISA |
台塑生醫科技股份有限公司宜蘭廠 Formosa Plastics Biomedical Technology Co., Ltd. Yilan Plant |
抗體檢測 Antibody |
| 35 | 2021/3/17 | 安特羅新型冠狀病毒抗原快速檢驗試劑 Enimmune Speedy COVID-19 Ag Rapid Test |
安特羅生物科技股份有限公司委託聯華生技股份有限公司製造 Manufactured by ENIMMUNE CORPORATION for FIRSTEP BIORESEARCH INC. |
抗原檢測 Antigen |
| 36 | 2021/4/6 | COVIDual COVID-19 IgM/IgG 快速檢測試劑 COVIDual COVID-19 IgM/IgG Rapid Test |
長興材料工業股份有限公司 ETERNAL MATERIALS CO., LTD. |
抗體檢測 Antibody |
| 37 | 2021/4/6 | COVIDual COVID-19 IgM/IgG 快速檢測試劑 COVIDual COVID-19 IgM/IgG Rapid Test |
長興材料工業股份有限公司委託聯華生技股份有限公司製造 Manufactured by FIRSTEP BIORESEARCH INC. for ETERNAL MATERIALS CO., LTD. |
抗體檢測 Antibody |
| 38 | 2021/4/7 | 美克優新型冠狀病毒S-RBD/S1-NTD抗體快速檢驗試劑 ViroCure CO-19 S-RBD/S1-NTD Ab Rapid Test |
東耀生物科技有限公司 TONYAR BIOTECH. INC. |
抗體檢測 Antibody |
| 39 | 2021/4/6 | COVID-19抗原快速檢測試劑 COVID-19 Antigen Rapid Test |
長興材料工業股份有限公司 ETERNAL MATERIALS CO., LTD. |
抗原檢測 Antigen |
| 40 | 2021/4/28 | 飛確 新型冠狀病毒抗原快速檢驗試劑 卡匣式 Vstrip COVID-19 Antigen Rapid Test cassette |
寶齡富錦生技股份有限公司汐止廠 Panion & BF Biotech Inc. Xizhi Factory |
抗原檢測 Antigen |
| 41 | 2021/5/10 | 伊諾來富新型冠狀病毒抗原檢驗試劑 ENNOLIFE COVID-19 Antigen Test |
保生國際生醫股份有限公司 PROTECTLIFE INTERNATIONAL BIOMEDICAL INC. |
抗原檢測 Antigen |
| 42 | 2021/5/10 | 凌越新型冠狀病毒抗原快速檢測試劑 EBSALERT SARS-CoV-2 Antigen Rapid Test |
凌越生醫股份有限公司臺北廠 EXCELSIOR BIO-SYSTEM INCORPORATION Taipei Factory |
抗原檢測 Antigen |
| 43 | 2021/5/14 | 百歐COVID19 Ag快速檢測試劑(IVD) AllBio COVID-19 Ag Rapid Test Kit |
百歐生命科技股份有限公司委託龍騰生技股份有限公司新市廠製造 Manufactured by LOMG TERM BIORESEARCH INC. for ALLBIO SCIENCE, INC. |
抗原檢測 Antigen |
| 44 | 2021/5/21 | 訊捷 新型冠狀病毒抗原快速檢驗試劑 ImmTek COVID-19 Antigen Rapid Test |
美特斯生醫股份有限公司委託寶齡富錦生技股份有限公司汐止廠製造 Manufactured by Panion & BF Biotech Inc. Xizhi Factory for METAS BIOMEDICAL INC. |
抗原檢測 Antigen |
| 45 | 2021/6/7 | 艾諾斯新冠病毒COVID-19抗原快速檢測試劑 Ainos SARS-CoV-2 Antigen Rapid Test Kit |
台灣奈米碳素股份有限公司 TAIWAN CARBON NANO TECHNOLOGY CORPORATION |
抗原檢測 Antigen |
| 46 | 2021/6/8 | 聯華新型冠狀病毒抗原快速檢測試劑 2019-nCoV Antigen Rapid Test |
聯華生技股份有限公司 FIRSTEP BIORESEARCH INC. |
抗原檢測 Antigen |
| 47 | 2021/6/17 | 福爾威創家用新型冠狀病毒抗原快速檢驗套組 FORA/VTRUST COVID-19 Antigen Self Test |
泰博科技股份有限公司五股廠 Taibo Technology Co., Ltd. Wugu Factory |
抗原檢測 Antigen |
| 48 | 2021/7/1 | 飛確RV2家用新型冠狀病毒抗原快速檢驗試劑 Vstrip RV2 COVID-19 Antigen Rapid Test Home Use |
寶齡富錦生技股份有限公司汐止廠 Panion & BF Biotech Inc. Xizhi Factory |
抗原檢測 Antigen |
| 49 | 2021/7/8 | 研準 新型冠狀病毒抗原快速檢驗試劑 ACADECISE COVID-19 Antigen Rapid Test |
中央研究院委託寶齡富錦生技股份有限公司汐止廠製造 Manufactured by Panion & BF Biotech Inc. Xizhi Factory for Academia Sinica |
抗原檢測 Antigen |
| 50 | 2021/8/2 | 嘉瑞新型冠狀病毒抗體快速檢測試劑組 Swiscare COVID-19 Antibody Detection Kit |
瑞智生化科技股份有限公司 SWISCARE TECHNOLOGY CO., LTD. |
抗體檢測 Antibody |
| 51 | 2021/8/13 | 飛確RV2新型冠狀病毒抗原快速檢驗試劑 Vstrip RV2 COVID-19 Antigen Rapid Test |
寶齡富錦生技股份有限公司汐止廠 Panion & BF Biotech Inc. Xizhi Factory |
抗原檢測 Antigen |
| 52 | 2021/8/25 | 瑩芳新型冠狀病毒COVID-19病毒抗原快速檢驗試劑 “IF ” COVID-19 Antigen Rapid Test |
瑩芳有限公司台中廠 IN FUNG CO., LTD. |
抗原檢測 Antigen |
| 53 | 2021/9/6 | 冷確新型冠狀病毒(SARS-CoV-2)抗原快速檢驗試劑 Q-Check SARS-CoV-2 Antigen Rapid Test |
冷泉港生物科技股份有限公司委託鼎群科技股份有限公司製造 Manufactured by TRISON TECHNOLOGY INTEGRATION CORPORATION for COLD SPRING BIOTECH CORP. |
抗原檢測 Antigen |
| 54 | 2021/9/7 | 碁米庫斯新冠病毒抗原快速檢驗試劑 KEMYTH cassette SARS-CoV-2 Antigen Rapid Test |
碁米庫斯生物科技股份有限公司委託鼎群科技股份有限公司製造 Manufactured by TRISON TECHNOLOGY INTEGRATION CORPORATION for KEMYTH BIOTECH CO., LTD. |
抗原檢測 Antigen |
| 55 | 2021/9/23 | 安盛安必測新冠肺炎抗原快速檢測分析儀 iXensor PixoTest Analyzer 安盛安必測新冠肺炎抗原快速檢測套組 iXensor PixoTest COVID-19 Ag Test Kit |
安盛生科股份有限公司內湖廠 IXENSOR CO., LTD. |
抗原檢測 Antigen |
| 56 | 2021/10/6 | 鼎群新冠肺炎抗原快速檢測試劑 TTREND COVID-19 Antigen Test |
鼎群科技股份有限公司 TRISON TECHNOLOGY INTEGRATION CORPORATION |
抗原檢測 Antigen |
| 57 | 2021/10/29 | 艾卡爾SARS-CoV-2試劑組 iCareDx SARS-CoV-2 test kit (PSS-1s-COVID-R) (1 test/kit) 艾卡爾SARS-CoV-2品管試劑組 iCareDx SARS-CoV-2 Control kit (PSS-1s-COVID-Q) (1 test/kit) 艾卡爾核酸檢測分析儀 iCareDx RT-PCR analyzer (PSS-1s-C) |
富佳生技股份有限公司 iCare Diagnostics International Co. Ltd. |
核酸檢測 Nucleic acid |
| 58 | 2021/11/19 | 福又達新型冠狀病毒多重螢光核酸檢驗試劑組 SBC SARS-CoV-2 MDx qPCR Kit |
台塑生醫科技股份有限公司 FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION |
核酸檢測 Nucleic acid |
| 59 | 2021/11/29 | 台塑生醫家用新型冠狀病毒抗原快速檢驗試劑 Formosa SARS-CoV-2 Antigen Self Test |
台塑生醫科技股份有限公司宜蘭廠 FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION Yilan Factory |
抗原檢測 Antigen |
| 60 | 2021/12/16 | 百敏析 SARS-CoV-2 IgG抗體檢測套組 BioIC SARS-CoV-2 IgG Detection Kit |
洹藝科技股份有限公司 AGNITIO SCIENCE & TECHNOLOGY, INC. |
抗體檢測 Antibody |
| 61 | 2021/12/27 | 矽基微量生醫分子檢測儀 Molsentech SENEDIA 矽基新冠病毒快速檢測晶片 Molsentech SARS-CoV-2 Bio-FET 矽基核酸檢測試劑 Molsentech RNA assay Kit |
矽基分子電測科技股份有限公司 SILICON-BASED MOLECULAR SENSORING TECHNOLOGY CO., LTD. |
核酸檢測 Nucleic acid |
| 62 | 2022/01/27 | 凌越家用新型冠狀病毒抗原快速檢測試劑 EBSALERT SARS-CoV-2 Antigen Self Test |
凌越生醫股份有限公司 EXCELSIOR BIO-SYSTEM INCORPORATION |
抗原檢測 Antigen |
| 63 | 2022/02/15 | 速可安家用新冠病毒抗原自我檢測套組 Quicksure COVID-19 Antigen Self Test |
安特羅生物科技股份有限公司委託聯華生技股份有限公司製造 Manufactured by FIRSTEP BIORESEARCH INC. for ENIMMUNE CORPORATION |
抗原檢測 Antigen |
| 64 | 2022/3/7 | 福爾威創新型冠狀病毒抗原快速檢驗試劑FORA/VTRUST COVID-19 Antigen Rapid Test 福爾威創新型冠狀病毒抗原快速檢驗試劑-陽性品管刷 FORA COVID-19 Antigen Postitive Control Swab 福爾威創新型冠狀病毒抗原快速檢驗試劑-陰性品管刷 FORA COVID-19 Antigen Negative Control Swab |
泰博科技股份有限公司五股廠 Taibo Technology Co., Ltd. Wugu Factory |
抗原檢測 Antigen |
| 65 | 2022/3/17 | 凌越新型冠狀病毒中和抗體檢測試劑 EBSALERT SARS-CoV-2 Neutralizing Antibody Detection ELISA |
凌越生醫股份有限公司 EXCELSIOR BIO-SYSTEM INCORPORATION |
抗體檢測 Antibody |
| 66 | 2022/3/28 | 普生新型冠狀病毒抗原快速檢測試劑 GB COVID-19 Ag Rapid Test |
普生股份有限公司 GENERAL BIOLOGICALS CORP. |
抗原檢測 Antigen |
| 67 | 2022/4/18 | 飛確RV2家用新型冠狀病毒抗原快速檢驗試劑 Vstrip RV2 COVID-19 Antigen Rapid Test HOME USE |
寶齡富錦生技股份有限公司汐止廠二廠 Panion & BF Biotech Inc. Xizhi Factory II |
抗原檢測 Antigen |
| 68 | 2022/4/18 | 長興家用COVID-19抗原快速檢測試劑套組 ETERNAL COVID-19 Antigen Self Test |
長興材料工業股份有限公司汐止廠 ETERNAL MATERIALS CO., LTD. Xizhi Plant |
抗原檢測 Antigen |
| 69 | 2022/5/13 | 普生家用新型冠狀病毒抗原快速檢測試劑 GB COVID-19 Ag Home Test |
普生股份有限公司 GENERAL BIOLOGICALS CORP. |
抗原檢測 Antigen |
| 70 | 2022/5/20 | 艾卡爾新冠病毒家用核酸檢測套組(鼻腔) iCareDx SARS-CoV-2 At-Home Nucleic Acid Test Kit (Nasal) 艾卡爾新冠病毒家用核酸品管物質套組 iCareDx SARS-CoV-2 At-Home Nucleic Acid Quality Control Kit 艾卡爾核酸檢測分析儀 iCareDx Real-Time PCR Analyzer |
富佳生技股份有限公司 iCare Diagnostics International Co. Ltd. |
核酸檢測 Nucleic acid |
| 71 | 2022/5/25 | 飛確 新型冠狀病毒S-RBD抗體快速檢驗試劑 Vstrip COVID-19 S-RBD Antibody Rapid Test< |
寶齡富錦生技股份有限公司汐止廠 Panion & BF Biotech Inc. Xizhi Factory |
抗體檢測 Antibody |
| 72 | 2022/6/13 2022/8/15 |
艾諾斯家用新冠病毒 COVID-19 抗原快速檢測試劑 Ainos SARS-CoV-2 Antigen Rapid Self Test |
台灣奈米碳素股份有限公司 Taiwan Carbon Nano Technology Corporation |
抗原檢測 Antigen |
| 73 | 2022/6/13 | 嘉瑞COVID-19抗原家用檢驗試劑 Swiscare COVID-19 Antigen Self-Testing Kit |
瑞智生化科技股份有限公司 Swiscare Technology Co., Ltd |
抗原檢測 Antigen |
| 74 | 2022/8/2 | 福又達新冠肺炎IgG抗體檢測試劑組 SBC COVID-19 IgG ELISA Kit |
福又達生物科技股份有限公司委託精專生醫股份有限公司製造 Manufactured by ACCUBIOMED CO., LTD. for SCHWEITZER BIOTECH COMPANY LTD. |
抗體檢測 Antibody |
| 75 | 2022/8/16 | 泉沂醫學新冠病毒核酸檢測試劑組 GENEONE COVID-19 Nucleic Acid Diagnostic Kit |
泉沂醫學科技股份有限公司 GeneOne Diagnostics Corporation |
核酸檢測 Nucleic acid |
| 76 | 2022/9/28 | 安必測新冠肺炎抗原家用快篩套組 PixoTest COVID-19 Antigen Self Test Kit |
安盛生科股份有限公司內湖廠 iXensor Co., LTD. Neihu Factory |
抗原檢測 Antigen |
| 77 | 2022/10/4 | 長興新型冠狀病毒SRBD抗體快速檢測試劑 ETERNAL SARS-CoV-2 SRBD Antibody Rapid Test |
長興材料工業股份有限公司汐止廠 ETERNAL MATERIALS CO., LTD. Xizhi Plant. |
抗體檢測 Antibody |
專案輸入新冠病毒檢驗試劑相關產品資訊清單
The imported COVID-19 IVD granted emergency use authorization by Ministry of Health and Welfare (MOHW), Taiwan
| 序號 No. |
核准日期 Approval date |
試劑名稱 Commercial Name |
製造商名稱 Manufacturer |
檢驗類型 Target |
|---|---|---|---|---|
| 1 | 2020/3/30 | SARS-COV-2 Antibody Test COVID-19 IgG/IgM Rapid Test |
廣州萬孚生物技術有限公司 Guangzhou Wondffo Biotech Co., Ltd |
抗體檢測 Antibody |
| 2 | 2020/4/8 | Xpert Xpress SARS-CoV-2 test | Cepheid Inc. | 核酸檢測 Nucleic acid |
| 3 | 2020/4/8 | Abbott RealTime SARS-CoV-2 Amplification Reagent Kit Abbott RealTime SARS-CoV-2 Control Kit |
Abbott Molecular Inc. | 核酸檢測 Nucleic acid |
| 4 | 2020/4/24 | 2019-nCoV Ab TEST CASSETEE | 英諾特(唐山)生物技術有限公司 Innovita (Tangshan) Biological Technology Co. Ltd |
抗體檢測 Antibody |
| 5 | 2020/4/24 | cobas® SARS-CoV-2試劑(P/N:09175431190) cobas® SARS-CoV-2 (P/N:09175431190) cobas® SARS-CoV-2 Control Kit (P/N:09175440190)" |
Roche Molecular Systems, Inc. | 核酸檢測 Nucleic acid |
| 6 | 2020/5/5 | DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit | Solgent Co., Ltd. | 核酸檢測 Nucleic acid |
| 7 | 2020/5/5 | Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit | 上海仁度生物科技 Shanghai Rendu Biotechnology Co., Ltd |
核酸檢測 Nucleic acid |
| 8 | 2020/5/8 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics Gmbh | 抗體檢測 Antibody |
| 9 | 2020/5/13 | TaqPath COVID-19 Combo Kit, 100 reaction TaqPath COVID-19 Combo Kit, 1000 reaction |
Life Technologies Corporation | 核酸檢測 Nucleic acid |
| 10 | 2020/5/14 | BioFire COVID-19 Test Kit BioFire COVID-19 Test Kit BioFire COVID-19 Test External Control Kit(+) |
Biofire Defense, LLC | 核酸檢測 Nucleic acid |
| 11 | 2020/5/19 | SARS-CoV-2 Reagents for BD MAX System | Becton Dikinson And Company | 核酸檢測 Nucleic acid |
| 12 | 2020/5/20 | Allplex 2019-nCoV Assay | Seegene Inc. | 核酸檢測 Nucleic acid |
| 13 | 2020/5/22 | SARS-Cov-2 IgG SARS-Cov-2 IgG Calibrator Kit SARS-Cov-2 IgG Control Kit |
Abbott Laboratories Diagnostics Division | 抗體檢測 Antibody |
| 14 | 2020/5/22 | Biofire respiratory panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 核酸檢測 Nucleic acid |
| 15 | 2020/5/27 | Panther Fusion Open Access RNA/DNA Enzyme cartridge Panther Fusion Internal Control-S Panther Fusion SARS-CoV-2 Assay Controls Panther Fusion Extraction Reagent-S Panther Fusion Elution Buffer Panther Fusion SARS-CoV-2 Assay PPR Solution Panther Fusion Oil Aptima Oil Reagent Panther Fusion Specimen Lysis Tubes Panther Fusion Module Panther Fusion Open Access Pack Panther Fusion Tube Trays |
Hologic,Inc. | 核酸檢測 Nucleic acid |
| 16 | 2020/6/8 | Logix Smart Coronavirus 2019 (COVID-19) Test Kit | Co-Diagnostics, Inc. | 核酸檢測 Nucleic acid |
| 17 | 2020/6/12 | STANDARD M nCoV Real-Time Detection kit | Sd Biosensor, Inc. | 核酸檢測 Nucleic acid |
| 18 | 2020/6/22 | 72710 Platelia SARS-CoV2 Total Ab | Bio-Rad | 抗體檢測 Antibody |
| 19 | 2020/7/8 | ADVIA Centaur SARS-CoV-2 Total (COV2T) ADVIA Centaur SARS-CoV-2 Total Quality Control (COV2T QC) |
Siemens Healthcare Diagnostics Inc. | 抗體檢測 Antibody |
| 20 | 2020/7/8 | Alinity m SARS-CoV-2 AMP Kit Alinity m SARS-CoV-2 CTRL Kit Alinity m System Alinity m Sample Prep Kit 2 Alinity m Lysis Solution Alinity m Diluent Solution Alinity m Vapor Barrier Solution |
Abbott Molecular Inc. | 核酸檢測 Nucleic acid |
| 21 | 2020/7/10 | ID NOW COVID-19 | Abbott Diagnostic Scarborough, Inc. | 核酸檢測 Nucleic acid |
| 22 | 2020/7/15 | Access SARS-CoV-2 IgG Access SARS-CoV-2 IgG calibrator Access SARS-CoV-2 IgG QC |
Beckman Coulter, Inc. | 抗體檢測 Antibody |
| 23 | 2020/8/5 | Biocode SARS COV 2 Assay Kit | Applied Biocode, Inc | 核酸檢測 Nucleic acid |
| 24 | 2020/8/31 | PreciControl Anti-SARS-CoV-2 品管液 PreciControl Anti-SARS-CoV-2 | Roche Diagnostics Gmbh | 抗體檢測 Antibody |
| 25 | 2020/9/16 | BD VERITOR SYSTEM FOR RAPID DETECTION OF SARS COV2 | Becton, Dickinson And Company | 抗原檢測 Antigen |
| 26 | 2020/9/16 | BD VERITOR SYSTEM FOR RAPID DETECTION OF SARS COV2 | Becton, Dickinson And Company | 抗原檢測 Antigen |
| 27 | 2020/11/4 | cobas SARS-CoV-2 & Influenza A/B cobas SARS-CoV-2 & Influenza A/B Quality Control Kit (P/N:09211128190) |
Roche Molecular Systems, Inc. | 核酸檢測 Nucleic acid |
| 28 | 2020/11/9 | Panbio COVID-19 Ag Rapid Test Device (Nasopharyngeal) | Abbott Rapid Diagnostics Jena Gmbh | 抗原檢測 Antigen |
| 29 | 2020/11/13 | cobas® SARS-CoV-2 & Influenza A/B (P/N: 09233474190) Influenza A/B Quality Control Kit (P/N:09233482190) |
Roche Molecular Systems, Inc. | 核酸檢測 Nucleic acid |
| 30-1 | 2020/11/24 | APTIMA SARS-CoV2 Assay APTIMA SARS-CoV 2 Controls Kit Hologic Specimen Lysis Tube Finisherbrand Versaclosure Tube Closures Replacement Caps TCF/Selection Replacement Caps Amp/Probe Replacement Caps Enzyme Hologic Bleach Enhancer for cleaning Specimen Transport Medium |
Hologic,Inc. | 核酸檢測 Nucleic acid |
| 30-2 | 2021/7/1 | Direct Load Tube Collection Kit | Hologic,Inc. | 核酸檢測 Nucleic acid |
| 31 | 2020/11/30 | Xpert Xpress SARS-CoV-2/Flu/RSV | Cepheid Inc. | 核酸檢測 Nucleic acid |
| 32 | 2020/12/14 | Elecsys Anti-SARS-CoV-2 S Elecsys Anti-SARS-CoV-2 S CalSet Anti-SARS-CoV-2 S PreciControl Anti-SARS-CoV-2 S |
Roche Diagnostics Gmbh | 抗體檢測 Antibody |
| 33 | 2020/12/28 | NeuMoDx Lysis Buffer 2 NeuMoDx Lysis Buffer 4 NeuMoDx Cartridge NeuMoDx Extraction Plate NeuMoDx Wash Solution, 2 L NeuMoDx Release Solution, 1 L NeuMoDx SARS-CoV-2 Test Strip NeuMoDx Viral Lysis Buffer NeuMoDx 96 Molecular System Installation Kit, NMDX 96 |
Neumodx Molecular, Inc. | 核酸檢測 Nucleic acid |
| 34 | 2021/1/5 | Biofire respiratory panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 核酸檢測 Nucleic acid |
| 35 | 2021/1/6 | Alinity m SARS CoV2 AMP KIT Alinity m SARS CoV2 CTRL KIT |
Abbot Molecular Inc. | 核酸檢測 Nucleic acid |
| 36 | 2021/1/7 | cobas SARS-CoV-2 cobas SARS-CoV-2 Control Kit |
Roche Molecular Systems, Inc. | 核酸檢測 Nucleic acid |
| 37 | 2021/1/19 | Virokey SARS CoV-2 RT PCR Test v2.0 | Vela Operations Singapore Pte Ltd | 核酸檢測 Nucleic acid |
| 38 | 2021/1/28 | TaqPath COVID-19 RT-PCR Kit Advanced TaqPath RT-PCR COVID-19 Kit TaqPath COVID-19 Control TaqPath COVID-19 Control Dilution Buffer |
Life Technologies Corporation | 核酸檢測 Nucleic acid |
| 39 | 2021/2/4 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics Gmbh | 抗體檢測 Antibody |
| 40 | 2021/2/9 | ACCESS SARS-CoV-2 IgG ACCESS SARS-CoV-2 IgG CALIBRATOR ACCESS SARS-CoV-2 IgG QC ACCESS SARS-CoV-2 IgM ACCESS SARS-CoV-2 IgM CALIBRATOR ACCESS SARS-CoV-2 IgM QC |
Beckman Coulter, Inc. | 抗體檢測 Antibody |
| 41 | 2021/2/9 | cobas SARS-CoV-2試劑 cobas SARS-CoV-2 Control Kit |
Roche Molecular Systems, Inc. | 核酸檢測 Nucleic acid |
| 42 | 2021/2/23 | Xpert Xpress SARS-CoV-2 | Cepheid Inc. | 核酸檢測 Nucleic acid |
| 43 | 2021/4/9 | AdviseDx SARS-CoV-2 IgG II (for Alinity) AdviseDx SARS-CoV-2 IgG II Calibrator Kit (for Alinity) AdviseDx SARS-CoV-2 IgG II Control Kit (for Alinity) AdviseDx SARS-CoV-2 IgG II (for Architect) AdviseDx SARS-CoV-2 IgG II Calibrator Kit (for Architect) AdviseDx SARS-CoV-2 IgG II Control Kit (for Architect) |
Abbott Ireland Diagnostics Division | 抗體檢測 Antibody |
| 44 | 2021/4/21 | Alinity m Resp-4-Plex AMP Kit Alinity m Resp-4-Plex CTRL Kit |
Abbott Molecular Inc. | 核酸檢測 Nucleic acid |
| 45 | 2021/4/21 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 核酸檢測 Nucleic acid |
| 46 | 2021/4/30 | QIAstat-Dx Operational Module? QIAstat-Dx Analytical Module QIAstat-Dx Respiratory SARS-CoV-2 Panel |
QIAGEN Gmbh | 核酸檢測 Nucleic acid |
| 47 | 2021/5/10 | Panbio COVID-19 Ag Rapid Test Device (NASAL) | Abbott Rapid Diagnostics Jena Gmbh | 抗原檢測 Antigen |
| 48 | 2021/5/17 | cPass SARS-CoV-2 Neutralization Antibody Detection Kit | Genscript USA,Inc. | 抗體檢測 Antibody |
| 49 | 2021/5/25 | BD Veritor System for Rapid Detection of SARS-Cov-2 | Becton, Dickinson And Company | 抗原檢測 Antigen |
| 50 | 2021/5/25 | ID NOW COVID-19 | Abbott Diagnostic Scarborough, Inc. | 核酸檢測 Nucleic acid |
| 51 | 2021/5/25 | Panbio COVID-19 Ag Rapid Test Device (Nasopharyngeal) | Abbott Rapid Diagnostics Jena Gmbh | 抗原檢測 Antigen |
| 52 | 2021/5/25 | Panbio COVID-19 Ag Rapid Test Device (NASAL) | Abbott Rapid Diagnostics Jena Gmbh | 抗原檢測 Antigen |
| 53-1 | 2021/5/25 | TaqPath RT-PCR COVID-19 Kit, 1,000 reactions TaqPath COVID-19 Control TaqPath COVID-19 Control Dilution Buffer |
Life Technologies Corporation | 核酸檢測 Nucleic acid |
| 53-2 | 2021/6/24 | MAGMAX Viral/Pathogen II Nucleic Acid Isolation Kit | Thermo Fisher Scientific Baltics Uab | 核酸檢測 Nucleic acid |
| 54 | 2021/5/25 | Alinity m SARS CoV2 AMP KIT Alinity m SARS CoV2 CTRL KIT |
Abbott Molecular Inc. | 核酸檢測 Nucleic acid |
| 55 | 2021/5/25 | Xpert Xpress SARS-CoV2 | Cepheid Inc. | 核酸檢測 Nucleic acid |
| 56 | 2021/5/26 | SARS-CoV-2 Reagents for BD MAX System | Becton Dikinson And Company | 核酸檢測 Nucleic acid |
| 57 | 2021/5/26 | cobas SARS-CoV-2 cobas SARS-CoV-2 cobas SARS-CoV-2 Control Kit cobas SARS-CoV-2 & Influenza A/B cobas SARS-CoV-2 & Influenza A/B Quality Control Kit |
Roche Molecular Systems, Inc. | 核酸檢測 Nucleic acid |
| 58 | 2021/5/28 | Xpert Xpress SARS-CoV-2 | Cepheid Inc. | 核酸檢測 Nucleic acid |
| 59 | 2021/6/7 | ADVIA Centaur SARS-CoV-2 Total (COV2T) ADVIA Centaur SARS-CoV-2 Total (COV2T) ADVIA Centaur SARS-CoV-2 Total Quality Control (COV2T QC) |
Siemens Healthcare Diagnostics Inc. | 抗體檢測 Antibody |
| 60 | 2021/6/7 | SARS-CoV-2 Rapid Antigen Test | Sd Biosensor, Inc. | 抗原檢測 Antigen |
| 61 | 2021/6/10 | GenBody COVID-19 Ag | Genbody Inc. | 抗原檢測 Antigen |
| 62 | 2021/6/10 | ACCESS SARS-CoV-2 IgM ACCESS SARS-CoV-2 IgM QC ACCESS SARS-CoV-2 IgM Calibrator ACCESS SARS-CoV-2 IgG ACCESS SARS-CoV-2 IgG Calibrator ACCESS SARS-CoV-2 IgG QC ACCESS SARS-CoV-2 IgG II ACCESS SARS-CoV-2 IgG II Calibrator ACCESS SARS-CoV-2 IgG II QC |
Beckman Coulter Inc. | 抗體檢測 Antibody |
| 63 | 2021/6/11 | APTIMA SARS-CoV-2 Assay Kit APTIMA SARS-CoV-2 Control Kit Hologic Specimen Lysis Tubes Hologic Specimen Lysis Tubes |
Hologic Inc. | 抗原檢測 Antigen |
| 64 | 2021/6/11 | Lucira CHECK-IT COVID-19 Test Kit | Lucira Health, Inc. | 核酸檢測 Nucleic acid |
| 65 | 2021/6/11 | Lucira CHECK- IT COVID-19 Test Kit | Lucira Health, Inc. | 核酸檢測 Nucleic acid |
| 66 | 2021/6/11 | ViroKey SARS-CoV-2 RT-PCR Test v2.0 | Vela Operations Singapore Pte Ltd | 核酸檢測 Nucleic acid |
| 67 | 2021/6/11 | SARS-CoV-2 Antigen Self Test Nasal | Sd Biosensor, Inc | 抗原檢測 Antigen |
| 68 | 2021/6/18 | STANDARD Q COVID-19 Ag STANDARD F COVID-19 Ag FIA |
Sd Biosensor, Inc. | 抗原檢測 Antigen |
| 69 | 2021/6/18 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics Gmbh | 抗體檢測 Antibody |
| 70 | 2021/6/21 | BD Veritor System for Rapid Detection of SARS-CoV-2 | Bd Rapid Diagnostic Suzhou Co Ltd | 核酸檢測 Nucleic acid |
| 71 | 2021/6/21 | SARS-CoV-2 IgG Kit SARS-CoV-2 IgG Calibrator Kit SARS-CoV-2 IgG Control Kit |
Abbott Laboratories | 抗體檢測 Antibody |
| 72 | 2021/6/22 | QuickVue AT-Home OTC COVID-19 Test QuickVue AT-Home OTC COVID-19 Test QuickVue AT-Home OTC COVID-19 Test |
Quidel Corporation | 抗原檢測 Antigen |
| 73 | 2021/6/22 | Biocode SARS-CoV-2 Assay Kit | Applied Biocode, Inc | 核酸檢測 Nucleic acid |
| 74 | 2021/6/22 | AdviseDx SARS-CoV-2 IgG II (for Alinity) AdviseDx SARS-CoV-2 IgG II Calibrator (for Alinity) AdviseDx SARS-CoV-2 IgG II Control (for Alinity) AdviseDx SARS-CoV-2 IgG II (for Architect) AdviseDx SARS-CoV-2 IgG II Calibrator Kit(for Architect) AdviseDx SARS-CoV-2 IgG II Control Kit(for Architect) |
Abbott Ireland Diagnostics Division | 抗體檢測 Antibody |
| 75 | 2021/6/22 | INNOSCREEN covid-19 Antigen Rapid Test Device | INNOVATION SCIENTIFIC PTY LTD | 抗原檢測 Antigen |
| 76 | 2021/6/23 | Humasis COVID-19 Ag Test | Humasis Co., Ltd. | 抗原檢測 Antigen |
| 77 | 2021/6/25 | GenBody COVID-19 Ag | Genbody Inc. | 抗原檢測 Antigen |
| 78 | 2021/6/28 | EURORealTime SARS-CoV-2 | Euroimmun Medizinische Labordiagnostika Ag | 核酸檢測 Nucleic acid |
| 79 | 2021/6/29 | MassARRAY SARS-CoV-2 Panel 試劑 | Agena Bioscience, Inc. | 核酸檢測 Nucleic acid |
| 80 | 2021/6/29 | TaqPath COVID-19 Pooling Assay Kit TaqPath COVID-19 Control Kit TaqPath COVID-19 Control Dilution Buffer TaqPath COVID-19 Module1/MS2 Phage Control TaqPath COVID-19 Module2 Assay Kit COVID-19 Control COVID-19 Module 2 Control Dilution Buffer |
Life Technologies Corporation | 核酸檢測 Nucleic acid |
| 81 | 2021/6/29 | GenBody COVID-19 Ag | Genbody Inc. | 抗原檢測 Antigen |
| 82 | 2021/7/1 | InteliSwab COVID-19 Rapid Test | Orasure Technologies, Inc. | 抗原檢測 Antigen |
| 83 | 2021/7/1 | AdviseDx SARS-CoV-2 IgM with Architect Reagent kit AdviseDx SARS-CoV-2 IgM with Architect Calibrator kit AdviseDx SARS-CoV-2 IgM with Architect Control kit AdviseDx SARS-CoV-2 IgM with Alinity Reagent kit AdviseDx SARS-CoV-2 IgM with Alinity Calibrator kit AdviseDx SARS-CoV-2 IgM with Alinity Control kit |
Abbott Ireland Diagnostics Division | 抗體檢測 Antibody |
| 84 | 2021/7/2 | cPass SARS-CoV-2 Neutralization Antibody Detection Kit | Genscript USA Inc. | 抗體檢驗 Antibody |
| 85 | 2021/7/5 | ADVIA Centaur SARS-CoV-2 IgG (sCOVG) ADVIA Centaur SARS-CoV-2 IgG Quality Control (sCOVG QC) |
Siemens Healthcare Diagnostics Inc. | 抗體檢測 Antibody |
| 86 | 2021/7/5 | CareStart COVID-19 Antigen | Access Bio | 抗原檢測 Antigen |
| 87 | 2021/7/7 | Anti-SARS-CoV-2 ELISA (IgG) | Euroimmun Medizinische Labordiagnostika Ag | 抗體檢測 Antibody |
| 88 | 2021/7/8 | Panbio COVID-19 Antigen SELF-TEST | Abbott Rapid Diagnostics Jena Gmbh | 抗原檢測 Antigen |
| 89 | 2021/7/8 | INNOSCREEN COVID-19 IgG/IgM Rapid Test Device | Innovation Scientific Pty Ltd | 抗體檢測 Antibody |
| 90 | 2021/7/8 ~2022/8/22 |
QuickVue SARS Antigen Test | Quidel Corporation | 抗原檢測 Antigen |
| 91 | 2021/7/8 | COVID-19 IgG/IgM Rapid Test Cassette | Hangzhou Clongene Biotech Co., Ltd. | 抗體檢測 Antibody |
| 92 | 2021/7/13 | STANDARD Q COVID-19 Ag Home Test | SD Biosensor Inc. | 抗原檢測 Antigen |
| 93 | 2021/7/14 | SARS-CoV-2 IgM Reagent for Alinity SARS-CoV-2 IgM Calibrator for Alinity SARS-CoV-2 IgM Control for Alinity SARS-CoV-2 IgM Reagent for ARCHITECT SARS-CoV-2 IgM Calibrator for ARCHITECT SARS-CoV-2 IgM Control for ARCHITECT |
Abbot Ireland Diagnostics Division | 抗體檢測 Antibody |
| 94 | 2021/7/14 | SARS-CoV-2 IgG reagent kit for Alinity SARS-CoV-2 IgG Calibrator kit for Alinity SARS-CoV-2 IgG Control kit for Alinity SARS-CoV-2 IgG reagent kit for Architect SARS-CoV-2 IgG Calibrator kit for Architect SARS-CoV-2 IgG Control kit for Architect |
Abbott Ireland Diagnostics Division | 抗體檢測 Antibody |
| 95 | 2021/7/14 | Biocredit COVID-19 Ag | RapiGEN Inc | 抗原檢測 Antigen |
| 96 | 2021/7/19 | Humasis COVID-19 Ag Home test | Humasis Co., Ltd. | 抗原檢測 Antigen |
| 97 | 2021/7/22 | DiaPlexQ Novel coronavirus (2019-nCoV) Detection Kit | Solgent Co.,Ltd | 核酸檢測 Nucleic acid |
| 98 | 2021/7/26 | Sofia SARS Antigen FIA | QUIDEL CORPORATION | 抗原檢測 Antigen |
| 99 | 2021/7/27 | Humasis COVID-19 Ag Test | Humasis Co., Ltd. | 抗原檢測 Antigen |
| 100 | 2021/7/28 | BIOCREDIT COVID-19 Ag Home Test Nasal | RapiGEN INC | 抗原檢測 Antigen |
| 101 | 2021/7/28 | SGTi-flex COVID-19 IgM/IgG | Sugentech, Inc. | 抗體檢測 Antibody |
| 102 | 2021/7/28 | BioPlex 2200 SARS-CoV IgG Reagent BioPlex 2200 SARS-CoV IgG Calibrator Set BioPlex 2200 SARS-CoV IgG Control Set |
BIO-RAD LABORATORIES INC. | 抗體檢測 Antibody |
| 103 | 2021/7/29 | Humasis COVID-19 Ag Home test | Humasis Co.,Ltd | 抗原檢測 Antigen |
| 104 | 2021/7/30 | QuantiVirus SARS-CoV-2 Test Kit | DiaCarta, Inc. | 核酸檢測 Nucleic acid |
| 105 | 2021/8/2 | SARS-CoV-2 IgG II Reagent for ARCHITECT SARS-CoV-2 IgG II Calibrator for ARCHITECT SARS-CoV-2 IgG II Control for ARCHITECT SARS-CoV-2 IgG II Reagent for Alinity SARS-CoV-2 IgG II Calibrator for Alinity SARS-CoV-2 IgG II Control for Alinity |
Abbott Ireland Diagnostics Division | 抗體檢測 Antibody |
| 106 | 2021/8/3 | BIOCREDIT COVID-19 Ag Home Test Nasal | RapiGEN INC | 抗原檢測 Antigen |
| 107 | 2021/8/4 | DiaPlexQ Novel Coronavirus (2019 nCoV) Detection Kit | Solgent Co.,Ltd | 核酸檢測 Nucleic acid |
| 108 | 2021/8/4 | STANDARD Q COVID-19 IgM/IgG Plus STANDARD F COVID-19 IgM/IgG Combo FIA |
SD BIOSENSOR, INC. | 抗體檢測 Antibody |
| 109 | 2021/8/5 | Celltrion DiaTrust COVID-19 Ag Home Test | Humasis Co., Ltd. | 抗原檢測 Antigen |
| 110 | 2021/8/9 | STANDARD Q COVID-19 Ag Test | SD Biosensor,Inc. | 抗原檢測 Antigen |
| 111 | 2021/8/10 | Celltrion DiaTrust COVID-19 Ag Home Test Kit | Humasis Co., Ltd. | 抗原檢測 Antigen |
| 112 | 2021/8/30 | BIOCREDIT COVID-19 Ag Home Test Nasal | RapiGEN INC | 抗原檢測 Antigen |
| 113 | 2021/8/30 | SARS-CoV-2 Rapid Antigen Test Nasal | SD BIOSENSOR, INC. | 抗原檢測 Antigen |
| 114 | 2021/8/30 | Humasis COVID-19 Ag Test | Humasis Co., Ltd. | 抗原檢測 Antigen |
| 115 | 2021/9/14 | Advanta Dx SARS-CoV-2 RT-PCR Assay | Fluidigm Corporation | 核酸檢測 Nucleic acid |
| 116 | 2021/9/14 | TaqPath COVID-19 Fast PCR Combo Kit 2.0 | Life Technologies Corporation | 核酸檢測 Nucleic acid |
| 117 | 2021/9/14 | BD Veritor System for Rapid Detection of SARS-CoV-2& Flu A+B | BECTON, DICKINSON AND COMPANY (BD) (OFFICE) | 抗原檢測 Antigen |
| 118 | 2021/9/15 | BD SARS-CoV-2/Flu for BD MAX System | BECTON,DICKINSON AND COMPANY | 核酸檢測 Nucleic acid |
| 119 | 2021/9/23 | CareStart COVID-19 Antigen | Access Bio, Inc. | 抗原檢測 Antigen |
| 120 | 2021/9/23 | TaqPath COVID-19 RNase P Kit 2.0 TaqPath COVID-19 Plus Control TaqPath COVID-19 Control Dilution Buffer TaqPath RT-PCR COVID-19,FluA,FluB Kit TaqPath RT-PCR COVID-19,FluA,FluB Control |
Life Technologies Corporation | 核酸檢測 Nucleic acid |
| 121 | 2021/10/7 | SARS-CoV-2 NGS ASSAY | Twist Bioscience Corporation | 核酸檢測 Nucleic acid |
| 122 | 2021/10/7 | VERI-Q Covid-19 Ag Rapid Test | MiCoBioMed Co.,Ltd | 抗原檢測 Antigen |
| 123 | 2020/10/25 | cPASSTM SARS-CoV-2 Neutralization Antibody Detection Kit | GenScript USA,Inc | 抗體檢測 Antibody |
| 124 | 2021/10/26 | CovAb SARS-CoV-2 Ab Test | Diabetomics, Inc. | 抗體檢測 Antibody |
| 125 | 2021/11/2 | Flowflex COVID-19 Antigen Home Test | ACON Laboratories, Inc. | 抗原檢測 Antigen |
| 126 | 2021/11/3 | GenBody COVID-19 Ag Home Test | GenBody Inc. | 抗原檢測 Antigen |
| 127 | 2021/11/4 | “ASAN”Easy Test COVID-19 Ag | Asan Pharmaceutical CO.,LTD. | 抗原檢測 Antigen |
| 128 | 2021/11/9 | VERI-Q COVID-19 Ag Rapid Test | ERA BIOTEQ ENTERPRISE CO., LTD. | 抗原檢測 Antigen |
| 129 | 2021/11/12 | Elecsys Anti-SARS-CoV-2 (cobas e 411/601/602) Elecsys Anti-SARS-CoV-2 (for cobas e 801) Precicontrol Anti-SARS-CoV-2 Elecsys Anti-SARS-CoV-2 S (cobas e 411/601/602) |
Roche Diagnostics GmbH | 抗原檢測 Antigen |
| 130 | 2021/12/06 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Calibrators VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls |
Ortho Clinical Diagnostics | 抗體檢測 Antibody |
| 131 | 2021/12/30 | Alinity m SARS-CoV-2 AMP kit Alinity m SARS-CoV-2 CTRL kit |
Abbot Molecular Inc. | 核酸檢測 Nucleic acid |
| 132 | 2022/2/09 | Xpert Xpress SARS-CoV-2 | Cepheid Inc. | 核酸檢測 Nucleic acid |
| 133 | 2022/2/15 | GenBody COVID-19 Ag Home Test | GENBODY INC. | 抗原檢測 Antigen |
| 134 | 2022/3/4 | Humasis COVID-19 Ag Test | Humasis Co., Ltd. | 抗原檢測 Antigen |
| 135 | 2022/3/28 | BioCode CoV-2 Flu Plus assay | Applied Biocode, Inc. | 核酸檢測 Nucleic acid |
| 136 | 2022/3/28 | Aptima SARS-CoV-2 Assay Kit | Hologic,Inc. | 核酸檢測 Nucleic acid |
| 137 | 2022/4/18 | Virokey SARS CoV-2 RT PCR Test v2.0 | Vela Operations Singapore Pte Ltd | 核酸檢測 Nucleic acid |
| 138 | 2022/4/19 | Allplex 2019-nCoV Assay | Seegene Inc. | 核酸檢測 Nucleic acid |
| 139 | 2022/4/21 | GenBody COVID-19 Ag Home Test | GENBODY INC. | 抗原檢測 Antigen |
| 140 | 2022/4/28 | GenBody COVID-19 Ag | GenBody Inc. | 抗原檢測 Antigen |
| 141 | 2022/4/29 | Gmate COVID-19 Ag Saliva | Philosys Co.,Ltd | 抗原檢測 Antigen |
| 142 | 2022/5/3 | BD kit for rapid detection of SARS-CoV-2 | BD Rapid Diagnostics (Suzhou) Co., Ltd. | 抗原檢測 Antigen |
| 143 | 2022/5/6 | Humasis COVID-19 Ag Test | Humasis Co., Ltd. | 抗原檢測 Antigen |
| 144 | 2022/5/9 | BIOCREDIT COVID-19 Ag Home Test Nasal | RapiGEN INC. | 抗原檢測 Antigen |
| 145 | 2022/5/10 | Flowflex COVID-19 Antigen Home Test | ACON Laboratories, Inc. | 抗原檢測 Antigen |
| 146 | 2022/5/10 | Humasis COVID-19 Ag Home Test | Humasis Co., Ltd. | 抗原檢測 Antigen |
| 147 | 2022/5/12 | Panbio COVID-19 Ag Rapid Test Device (NASAL) | Abbott Rapid Diagnostics Jena GmbH | 抗原檢測 Antigen |
| 148 | 2022/5/13 | InnoScreen COVID-19 Antigen Rapid Test Device (Self-Test) | INNOVATION SCIENTIFIC PTY LTD | 抗原檢測 Antigen |
| 149 | 2022/5/13 | Indicaid covid-19 rapid antigen at-home test | Phase Scientific International Limited | 抗原檢測 Antigen |
| 150 | 2022/5/13 | Panbio COVID-19 Ag Rapid Test Device(Nasopharyngeal) | Abbott Rapid Diagnostics Jena GmbH | 抗原檢測 Antigen |
| 151 | 2022/5/16 | Xpert Xpress SARS-CoV-2 | CEPHEID | 核酸檢測 Nucleic acid |
| 152 | 2022/5/20 | Humasis COVID-19 Ag Home test | Humasis Co.,Ltd | 抗原檢測 Antigen |
| 153 | 2022/5/20 | STANDARD Q COVID-19 Ag Home Test | SD BIOSENSOR, INC. | 抗原檢測 Antigen |
| 154 | 2022/5/20 | STANDARD Q COVID-19 Ag Home Test | SD Biosensor, Inc. | 抗原檢測 Antigen |
| 155 | 2022/5/20 | InnoScreen COVID-19 Antigen Rapid Test Device | Innovation Scientific Pty Ltd | 抗原檢測 Antigen |
| 156 | 2022/5/20 | DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit | SolGent Co., Ltd | 核酸檢測 Nucleic acid |
| 157 | 2022/5/23 | PCL SELF TEST-COVID19 Ag | PCL, Inc | 抗原檢測 Antigen |
| 158 | 2022/5/23 | INDICAID COVID-19 Rapid Antigen At-home test | PHASE Scientific International Ltd. | 抗原檢測 Antigen |
| 159 | 2022/5/25 | DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit | SolGent Co., Ltd. | 核酸檢測 Nucleic acid |
| 160 | 2022/6/6 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls |
Ortho-Clinical Diagnostics, Inc. | 抗體檢測 Antibody |
| 161 | 2022/6/6 | PCL SELF TEST-COVID19 Ag | PCL,Inc. | 抗原檢測 Antigen |
| 162 | 2022/6/8 | VERI-Q COVID-19 Ag Rapid Test | MiCo BioMed Co., Ltd | 抗原檢測 Antigen |
| 163 | 2022/6/10 | Rapid ResponseTM COVID-19 Antigen Rapid Test Cassette - At Home | BTNX, INC. | 抗原檢測 9Antigen |
| 164 | 2022/6/10 | NeuMoDx Lysis Buffer 2 NeuMoDx Lysis Buffer 3 NeuMoDx Cartridge NeuMoDx Extraction Plate NeuMoDx Wash Solution, 2 L NeuMoDx Release Solution, 1 L NeuMoDx SARS-CoV-2 Test Strip NeuMoDx Viral Lysis Buffer NeuMoDx Saliva Collection Kit NeuMoDx 96 Molecular System NeuMoDx 288 Molecular System |
NeuMoDx Molecular, Inc. | 核酸檢測 Nucleic acid |
| 165 | 2022/6/10 | BIOCREDIT COVID-19 Ag Home Test Nasal | RapiGEN, Inc. | 抗原檢測 Antigen |
| 166 | 2022/8/9 | PCL SELF TEST COVID19 Ag | PCL Inc. | 抗原檢測 Antigen |
| 167 | 2022/8/11 | TaqPath COVID-19 RNase P Kit 2.0 TaqPath COVID-19 Plus Control TaqPath COVID-19 Control Dilution Buffer |
Life Technologies Corporation Microgenics Corporation Life Technologies Corporation |
核酸檢測 Nucleic acid |
| 168 | 2022/8/17 | TaqPath COVID-19 Module1/MS2 Phage Control、TaqPath COVID-19 Module2 Assay Kit COVID-19 Control COVID-19 Module 2 Control Dilution Buffer |
Life Technologies Corporation Microgenics Corporation Life Technologies Corporation |
核酸檢測 Nucleic acid |
| 169 | 2022/8/18 | obas SARS-CoV-2 Duo cobas SARS-CoV-2 Duo Control Kit |
Roche Molecular Systems, Inc. | 核酸檢測 Nucleic acid |
| 170 | 2022/8/18 | Xpert Xpress CoV-2 plus | Cepheid | 核酸檢測 Nucleic acid |
| 171 | 2022/8/18 | cobas SARS-CoV-2 cobas SARS-CoV-2 Control Kit |
Roche Molecular Systems, Inc. | 核酸檢測 Nucleic acid |
| 172 | 2022/8/19 | TaqPath RT-PCR COVID-19 Kit TaqPath RT-PCR COVID-19 Control TaqPath RT-PCR COVID-19 Control Dilution Buffer |
Life Technologies Corporation Microgenics Corporation Life Technologies Corporation |
核酸檢測 Nucleic acid |
| 173 | 2022/8/19 | PCL SELF TEST-COVID19 Ag | PCL,Inc. | 抗原檢測 Antigen |
| 174 | 2022/8/19 | PCL SELF TEST COVID19 Ag | PCL,Inc. | 抗原檢測 Antigen |
| 175 | 2022/8/23 | PCL SELF TEST COVID19 Ag | PCL,Inc. | 抗原檢測 Antigen |
| 176 | 2022/8/24 | ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 核酸檢測 Nucleic acid |
| 177 | 2022/8/30 | PCL SELF TESTCOVID19 Ag | PCL,Inc. | 抗原檢測 Antigen |
| 178 | 2022/9/13 | BioFire Respiratory Panel 2.1 (RP2.1) | BioFire Diagnostic, LLC | 核酸檢測 Nucleic acid |
| 179 | 2022/9/16 | Xpert Xpress SARS-CoV-2 /Flu/RSV plus | Cepheid | 核酸檢測 Nucleic acid |
| 180 | 2022/10/5 | STANDARD M10 SARS-CoV-2 STANDARD M10 |
SD Biosensor, Inc. | 核酸檢測 Nucleic acid |
- 發布日期：110-10-22
- 更新日期：111-10-13
- 發布單位：資訊處
- 點閱次數：