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核准疫苗及檢驗試劑清單

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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

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http://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

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 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
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112 2021/8/30 BIOCREDIT COVID-19 Ag Home Test Nasal RapiGEN INC 抗原檢測
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113 2021/8/30 SARS-CoV-2 Rapid Antigen Test Nasal SD BIOSENSOR, INC. 抗原檢測
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114 2021/8/30 Humasis COVID-19 Ag Test Humasis Co., Ltd. 抗原檢測
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115 2021/9/14 Advanta Dx SARS-CoV-2 RT-PCR Assay Fluidigm Corporation 核酸檢測
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116 2021/9/14 TaqPath COVID-19 Fast PCR Combo Kit 2.0 Life Technologies Corporation 核酸檢測
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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
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118 2021/9/15 BD SARS-CoV-2/Flu for BD MAX System BECTON,DICKINSON AND COMPANY 核酸檢測
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119 2021/9/23 CareStart COVID-19 Antigen Access Bio, Inc. 抗原檢測
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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
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121 2021/10/7 SARS-CoV-2 NGS ASSAY Twist Bioscience Corporation    核酸檢測
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122 2021/10/7 VERI-Q Covid-19 Ag Rapid Test MiCoBioMed Co.,Ltd 抗原檢測
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123 2020/10/25 cPASSTM SARS-CoV-2 Neutralization Antibody Detection Kit GenScript USA,Inc 抗體檢測
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124 2021/10/26 CovAb SARS-CoV-2 Ab Test Diabetomics, Inc. 抗體檢測
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125 2021/11/2 Flowflex COVID-19 Antigen Home Test ACON Laboratories, Inc. 抗原檢測
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126 2021/11/3 GenBody COVID-19 Ag Home Test GenBody Inc. 抗原檢測
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127 2021/11/4 “ASAN”Easy Test COVID-19 Ag Asan Pharmaceutical CO.,LTD. 抗原檢測
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128 2021/11/9 VERI-Q COVID-19 Ag Rapid Test ERA BIOTEQ ENTERPRISE CO., LTD. 抗原檢測
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129 2021/11/12 Elecsys Anti-SARS-CoV-2
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130 2021/12/06 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack
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131 2021/12/30 Alinity m SARS-CoV-2 AMP kit
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132 2022/2/09 Xpert Xpress SARS-CoV-2 Cepheid Inc. 核酸檢測
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133 2022/2/15 GenBody COVID-19 Ag Home Test GENBODY INC. 抗原檢測
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134 2022/3/4 Humasis COVID-19 Ag Test Humasis Co., Ltd. 抗原檢測
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135 2022/3/28 BioCode CoV-2 Flu Plus assay Applied Biocode, Inc. 核酸檢測
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136 2022/3/28 Aptima SARS-CoV-2 Assay Kit Hologic,Inc. 核酸檢測
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137 2022/4/18 Virokey SARS CoV-2 RT PCR Test v2.0 Vela Operations Singapore Pte Ltd 核酸檢測
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138 2022/4/19 Allplex 2019-nCoV Assay Seegene Inc. 核酸檢測
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139 2022/4/21 GenBody COVID-19 Ag Home Test GENBODY INC. 抗原檢測
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140 2022/4/28 GenBody COVID-19 Ag GenBody Inc. 抗原檢測
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141 2022/4/29 Gmate COVID-19 Ag Saliva Philosys Co.,Ltd 抗原檢測
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142 2022/5/3 BD kit for rapid detection of SARS-CoV-2 BD Rapid Diagnostics (Suzhou) Co., Ltd. 抗原檢測
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143 2022/5/6 Humasis COVID-19 Ag Test Humasis Co., Ltd. 抗原檢測
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144 2022/5/9 BIOCREDIT COVID-19 Ag Home Test Nasal RapiGEN INC. 抗原檢測
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145 2022/5/10 Flowflex COVID-19 Antigen Home Test ACON Laboratories, Inc. 抗原檢測
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146 2022/5/10 Humasis COVID-19 Ag Home Test Humasis Co., Ltd. 抗原檢測
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147 2022/5/12 Panbio COVID-19 Ag Rapid Test Device (NASAL) Abbott Rapid Diagnostics Jena GmbH 抗原檢測
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148 2022/5/13 InnoScreen COVID-19 Antigen Rapid Test Device (Self-Test) INNOVATION SCIENTIFIC PTY LTD 抗原檢測
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149 2022/5/13 Indicaid covid-19 rapid antigen at-home test Phase Scientific International Limited 抗原檢測
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150 2022/5/13 Panbio COVID-19 Ag Rapid Test Device(Nasopharyngeal) Abbott Rapid Diagnostics Jena GmbH 抗原檢測
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151 2022/5/16 Xpert Xpress SARS-CoV-2 CEPHEID 核酸檢測
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152 2022/5/20 Humasis COVID-19 Ag Home test Humasis Co.,Ltd 抗原檢測
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153 2022/5/20 STANDARD Q COVID-19 Ag Home Test SD BIOSENSOR, INC. 抗原檢測
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154 2022/5/20 STANDARD Q COVID-19 Ag Home Test SD Biosensor, Inc. 抗原檢測
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155 2022/5/20 InnoScreen COVID-19 Antigen Rapid Test Device Innovation Scientific Pty Ltd 抗原檢測
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156 2022/5/20 DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit SolGent Co., Ltd 核酸檢測
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157 2022/5/23 PCL SELF TEST-COVID19 Ag PCL, Inc 抗原檢測
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158 2022/5/23 INDICAID COVID-19 Rapid Antigen At-home test PHASE Scientific International Ltd. 抗原檢測
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  • 發布日期:110-10-22
  • 更新日期:111-05-26
  • 發布單位:資訊處
  • 點閱次數:0
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