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The COVID-19 vaccines granted emergency use authorization by Ministry of Health and Welfare (MOHW), Taiwan

No. Vaccine name Approval date
1 AstraZeneca COVID-19 Vaccine (Vaxzevria) 2021/02/20
2 Moderna COVID-19 Vaccine (Spikevax) 2021/04/22
3 MVC COVID-19 Vaccine 2021/07/30
4 BNT162b2 COVID-19 Vaccine 2021/08/03

For the Chinese instructions of the above vaccines, please refer to the official website of Taiwan Food and Drug Administration:https://www.fda.gov.tw/TC/siteList.aspx?sid=11845


The domestic COVID-19 IVD granted emergency use authorization by Ministry of Health and Welfare (MOHW), Taiwan

No. Approval date Commercial Name Manufacturer Target
1 2020/4/30 POCKIT Central SARS-CoV-2 (orf 1ab) Premix Kit
POCKIT Central Nucleic Acid Analyzer
POCKIT Central Cartridge Set (B)
POCKIT Central SARS-CoV-2 (orf 1ab) P(+) Control Reagent
GeneReach Biotechnology Corporation Nucleic acid
2 2020/5/11 LabTurbo AIO COVID-19 RNA Testing Kit
LabTurbo Viral DNA/RNA AIO extraction Kit
LabTurbo AIO SP-qPCR Automation System
Taigen Bioscience Corporation Nucleic acid
3 2020/5/25 MVC SARS-CoV-2 qPCR Kit Manufactured by (FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION) for (MEDIGEN VACCINE BIOLOGICS CORPORATION) Nucleic acid
4 2020/5/29 ALERT SARS-CoV-2 Antibody Rapid Test EXCELSIOR BIO-SYSTEM INCORPORATION Taipei Factory Antibody
5 2020/6/10 GB SARS-CoV-2 Real-time RT-PCR GENERAL BIOLOGICALS CORP. Nucleic acid
6 2020/6/30 KimForest SARS-CoV-2 Detection Kit v1 Manufactured by Pharmigene Inc. for KimForest Enterprise Co., Ltd. Nucleic acid
7 2020/7/1 GENEONE COVID-19 Nucleic Acid Diagnostic Kit GeneOne Diagnostics Corporation Nucleic acid
8 2020/7/1 VitaPCR SARS-CoV-2 Assay
VitaPCR Instrument
VitaPCR SARS-CoV-2 External Control Set
TRENTRON BIOMEDICAL LTD. Nucleic acid
9 2020/7/6 SARS-CoV-2 iPMx
SARS-CoV-2 Reagent Kit

 

SARS-CoV-2 iPMx
SARS-CoV-2 Control Kit

 

SARS-CoV-2 iPMx
SARS-CoV-2 iPMx Molecular Rapid Test System
Industrial Technology Research Institute, Medical Device GMP Manufacturer Nucleic acid
10 2020/7/24 Innocreate SARS-CoV-2 QD Kit Innocreate Bioscience Co., Ltd. Nucleic acid
11 2020/7/24 ExProbe SARS-CoV-2 Testing Kit TBG BIOTECHNOLOGY CORP. Nucleic acid
12 2020/7/27 COVID-19 Antibody Rapid Test TRISON TECHNOLOGY INTEGRATION CORPORATION Antibody
13 2020/8/12 COVIDual COVID-19 antibody Rapid Test ETERNAL MATERIALS CO., LTD. Antibody
14 2020/8/20
2022/2/23
IntelliPlex SARS-CoV-2 Detection Kit PLEXBIO CO., LTD. Nucleic acid
15 2020/8/24 ASK COVID-19 Antibody Rapid Test TONYAR BIOTECH. INC. Antibody
16 2020/8/27 Vstrip COVID-19 Antigen Rapid Test Panion & BF Biotech Inc. Xizhi Factory Antigen
17 2020/9/1 COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) For in vitro diagnosis Manufactured by LOMG TERM BIORESEARCH INC. for AllBio Science, Inc. Antibody
18 2020/9/16 GB SARS-CoV-2 Real-time RT-PCR
GB SimPrep Viral DNA/RNA Extraction Kit
GENERAL BIOLOGICALS CORP. Nucleic acid
19 2020/11/13 LabTurbo AIO COVID-19 RNA Testing Kit Taigen Bioscience Corporation Second Factory Nucleic acid
20 2020/11/13 VTRUST COVID-19 (SARS-CoV-2)Antigent Rapid Test Taibo Technology Co., Ltd. Wugu Factory Antigen
21 2020/11/23 DigiChip SARS-CoV-2 Assay Kit
Q Station
QUARK BIOSCIENCES TAIWAN, INC. Nucleic acid
22 2020/12/2 Dagene G SARS-CoV-2 Test Assay
Dagene GS1 Nucleic Acid Extraction Kit
Dagene G1 Automated Nucleic Acid Analysis System
Manufactured by ISTAT BIOMEDICAL CO., LTD. for DELBIO, INC.
Manufactured by ISTAT BIOMEDICAL CO., LTD. for DELBIO, INC.
Manufactured by CHROMA ATE INC. LINKOU PLANT for DELBIO, INC.
Nucleic acid
23 2020/12/14 ACE COVID-19 Antibody Rapid Detection Kit Manufactured by (SWISCARE TECHNOLOGY CO., LTD.)  for (ACE BIOLABS CO., LTD.) Antibody
24 2020/12/22 SBC SARS-CoV-2 MDx qPCR Kit Manufactured by FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION for SCHWEITZER BIOTECH COMPANY LTD. Nucleic acid
25 2020/12/30 MobioSense COVID-19 Isothermal Nucleic Acid Diagnostic Kit Manufactured by GeneOne Diagnostics Co., Ltd. for MobioSense Corp. Nucleic acid
26 2021/1/5 Dagene M SARS-CoV-2 Assay Manufactured by (ISTAT BIOMEDICAL CO., LTD.) for (DELBIO INC.) Nucleic acid
27 2021/1/11 GB SARS-CoV-2 Ab ELISA GENERAL BIOLOGICALS CORP. Antibody
28 2021/1/12 Formosa One Sure SARS-CoV-2 Ag Rapid Test Kit FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION Yilan Plant Antigen
29 2021/1/12 POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent
POCKIT Central Cartridge Set (B)
GeneReach Biotechnology Corporation Nucleic acid
30 2021/1/21 GBC SimPrep SARS-CoV-2 RT-PCR GENERAL BIOLOGICALS CORP. Nucleic acid
31 2021/1/28 “Abnova” COVID-19 Viral Antigen Rapid Test Manufactured by Long Term Bioresearch Inc. Xinshi Factory for Abnova (Taiwan) Corporation Antigen
32 2021/2/4 TRICAN COVID-19 Antigen Rapid Test Kit Manufactured by (TRISON TECHNOLOGY INTEGRATION CORPORATION) for (TRICAN BIOTECHNOLOGY CO., LTD.) Antigen
33 2021/2/17 SBC COVID-19 IgG ELISA Kit Manufactured by SCHWEITZER BIOTECH COMPANY LTD. for ACCUBIOMED CO., LTD. Antibody
34 2021/3/5 MeDiPro SARS-CoV-2 Antibody ELISA Formosa Plastics Biomedical Technology Co., Ltd. Yilan Plant Antibody
35 2021/3/17 Enimmune Speedy COVID-19 Ag Rapid Test Manufactured by ENIMMUNE CORPORATION for FIRSTEP BIORESEARCH INC. Antigen
36 2021/4/6 COVIDual COVID-19 IgM/IgG Rapid Test ETERNAL MATERIALS CO., LTD. Antibody
37 2021/4/6 COVIDual COVID-19 IgM/IgG Rapid Test Manufactured by FIRSTEP BIORESEARCH INC. for ETERNAL MATERIALS CO., LTD. Antibody
38 2021/4/7 ViroCure CO-19 S-RBD/S1-NTD Ab Rapid Test TONYAR BIOTECH. INC. Antibody
39 2021/4/6 COVID-19 Antigen Rapid Test ETERNAL MATERIALS CO., LTD. Antigen
40 2021/4/28 Vstrip COVID-19 Antigen Rapid Test cassette Panion & BF Biotech Inc. Xizhi Factory Antigen
41 2021/5/10 ENNOLIFE COVID-19 Antigen Test PROTECTLIFE INTERNATIONAL BIOMEDICAL INC. Antigen
42 2021/5/10 EBSALERT SARS-CoV-2 Antigen Rapid Test EXCELSIOR BIO-SYSTEM INCORPORATION Taipei Factory Antigen
43 2021/5/14 AllBio COVID-19 Ag Rapid Test Kit Manufactured by LOMG TERM BIORESEARCH INC. for ALLBIO SCIENCE, INC. Antigen
44 2021/5/21 ImmTek COVID-19 Antigen Rapid Test Manufactured by Panion & BF Biotech Inc. Xizhi Factory for METAS BIOMEDICAL INC. Antigen
45 2021/6/7 Ainos SARS-CoV-2 Antigen Rapid Test Kit TAIWAN CARBON NANO TECHNOLOGY CORPORATION Antigen
46 2021/6/8 2019-nCoV Antigen Rapid Test FIRSTEP BIORESEARCH INC. Antigen
47 2021/6/17 FORA/VTRUST COVID-19 Antigen Self Test Taibo Technology Co., Ltd. Wugu Factory Antigen
48 2021/7/1 Vstrip RV2 COVID-19 Antigen Rapid Test Home Use Panion & BF Biotech Inc. Xizhi Factory Antigen
49 2021/7/8 ACADECISE COVID-19 Antigen Rapid Test Manufactured by Panion & BF Biotech Inc. Xizhi Factory for Academia Sinica Antigen
50 2021/8/2 Swiscare COVID-19 Antibody Detection Kit SWISCARE TECHNOLOGY CO., LTD. Antibody
51 2021/8/13 Vstrip RV2 COVID-19 Antigen Rapid Test Panion & BF Biotech Inc. Xizhi Factory Antigen
52 2021/8/25 “IF ” COVID-19 Antigen Rapid Test IN FUNG CO., LTD. Antigen
53 2021/9/6 Q-Check SARS-CoV-2 Antigen Rapid Test Manufactured by TRISON TECHNOLOGY INTEGRATION CORPORATION for COLD SPRING BIOTECH CORP. Antigen
54 2021/9/7 KEMYTH cassette SARS-CoV-2 Antigen Rapid Test Manufactured by TRISON TECHNOLOGY INTEGRATION CORPORATION for KEMYTH BIOTECH CO., LTD. Antigen
55 2021/9/23  iXensor PixoTest Analyzer
 iXensor PixoTest COVID-19 Ag Test Kit
 IXENSOR CO., LTD. Antigen
56 2021/10/6 TTREND COVID-19 Antigen Test TRISON TECHNOLOGY INTEGRATION CORPORATION Antigen
57 2021/10/29 iCareDx SARS-CoV-2 test kit (PSS-1s-COVID-R) (1 test/kit)
iCareDx SARS-CoV-2 Control kit (PSS-1s-COVID-Q) (1 test/kit)
iCareDx RT-PCR analyzer (PSS-1s-C)
iCare Diagnostics International Co. Ltd. Nucleic acid
58 2021/11/19 SBC SARS-CoV-2 MDx qPCR Kit FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION Nucleic acid
59 2021/11/29 Formosa SARS-CoV-2 Antigen Self Test FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION Yilan Factory Antigen
60 2021/12/16 BioIC SARS-CoV-2 IgG Detection Kit AGNITIO SCIENCE & TECHNOLOGY, INC. Antibody
61 2021/12/27 Molsentech SENEDIA
Molsentech SARS-CoV-2 Bio-FET
Molsentech RNA assay Kit
SILICON-BASED MOLECULAR SENSORING TECHNOLOGY CO., LTD. Nucleic acid
62 2022/01/27 EBSALERT SARS-CoV-2 Antigen Self Test EXCELSIOR BIO-SYSTEM INCORPORATION Antigen
63 2022/02/15 Quicksure COVID-19 Antigen Self Test Manufactured by FIRSTEP BIORESEARCH INC. for ENIMMUNE CORPORATION Antigen
64 2022/3/7 FORA/VTRUST COVID-19 Antigen Rapid Test
FORA COVID-19 Antigen Postitive Control Swab
FORA COVID-19 Antigen Negative Control Swab
Taibo Technology Co., Ltd. Wugu Factory Antigen
65 2022/3/17 EBSALERT SARS-CoV-2 Neutralizing Antibody Detection ELISA EXCELSIOR BIO-SYSTEM INCORPORATION Antibody
66 2022/3/28 GB COVID-19 Ag Rapid Test GENERAL BIOLOGICALS CORP. Antigen
67 2022/4/18 Vstrip RV2 COVID-19 Antigen Rapid Test HOME USE Panion & BF Biotech Inc. Xizhi Factory II Antigen
68 2022/4/18 ETERNAL COVID-19 Antigen Self Test ETERNAL MATERIALS CO., LTD. Xizhi Plant Antigen
69 2022/5/13 GB COVID-19 Ag Home Test GENERAL BIOLOGICALS CORP. Antigen
70 2022/5/20 iCareDx SARS-CoV-2 At-Home Nucleic Acid Test Kit (Nasal)

iCareDx SARS-CoV-2 At-Home Nucleic Acid Quality Control Kit

iCareDx Real-Time PCR Analyzer
iCare Diagnostics International Co. Ltd. Nucleic acid

The imported COVID-19 IVD granted emergency use authorization by Ministry of Health and Welfare (MOHW), Taiwan

No. Approval date Commercial Name Manufacturer Target
1 2020/3/30 SARS-COV-2 Antibody Test
COVID-19 IgG/IgM Rapid Test
Guangzhou Wondffo Biotech Co., Ltd Antibody
2 2020/4/8 Xpert Xpress SARS-CoV-2 test Cepheid Inc. Nucleic acid
3 2020/4/8 Abbott RealTime SARS-CoV-2 Amplification Reagent Kit
Abbott RealTime SARS-CoV-2 Control Kit
Abbott Molecular Inc. Nucleic acid
4 2020/4/24 2019-nCoV Ab TEST CASSETEE Innovita (Tangshan) Biological Technology Co. Ltd Antibody
5 2020/4/24 cobas® SARS-CoV-2 (P/N:09175431190)
cobas® SARS-CoV-2 Control Kit (P/N:09175440190)"
Roche Molecular Systems, Inc. Nucleic acid
6 2020/5/5  DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit Solgent Co., Ltd. Nucleic acid
7 2020/5/5 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit Shanghai Rendu Biotechnology Co., Ltd Nucleic acid
8 2020/5/8 Elecsys Anti-SARS-CoV-2 Roche Diagnostics Gmbh Antibody
9 2020/5/13 TaqPath COVID-19 Combo Kit, 100 reaction
TaqPath COVID-19 Combo Kit, 1000 reaction
Life Technologies Corporation 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 Nucleic acid
11 2020/5/19 SARS-CoV-2 Reagents for BD MAX System Becton Dikinson And Company Nucleic acid
12 2020/5/20 Allplex 2019-nCoV Assay Seegene Inc. 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 Antibody
14 2020/5/22 Biofire respiratory panel 2.1 (RP2.1) Biofire Diagnostics, LLC 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. Nucleic acid
16 2020/6/8 Logix Smart Coronavirus 2019 (COVID-19) Test Kit Co-Diagnostics, Inc. Nucleic acid
17 2020/6/12 STANDARD M nCoV Real-Time Detection kit Sd Biosensor, Inc. Nucleic acid
18 2020/6/22 72710 Platelia SARS-CoV2 Total Ab Bio-Rad 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. 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. Nucleic acid
21 2020/7/10 ID NOW COVID-19 Abbott Diagnostic Scarborough, Inc. 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. Antibody
23 2020/8/5 Biocode SARS COV 2 Assay Kit Applied Biocode, Inc Nucleic acid
24 2020/8/31 PreciControl Anti-SARS-CoV-2 Roche Diagnostics Gmbh Antibody
25 2020/9/16 BD VERITOR SYSTEM FOR RAPID DETECTION OF SARS COV2 Becton, Dickinson And Company Antigen
26 2020/9/16 BD VERITOR SYSTEM FOR RAPID DETECTION OF SARS COV2 Becton, Dickinson And Company 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. Nucleic acid
28 2020/11/9 Panbio COVID-19 Ag Rapid Test Device (Nasopharyngeal) Abbott Rapid Diagnostics Jena Gmbh 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. 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. Nucleic acid
30-2 2021/7/1 Direct Load Tube Collection Kit Hologic,Inc. Nucleic acid
31 2020/11/30 Xpert Xpress SARS-CoV-2/Flu/RSV Cepheid Inc. 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 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. Nucleic acid
34 2021/1/5 Biofire respiratory panel 2.1 (RP2.1) Biofire Diagnostics, LLC Nucleic acid
35 2021/1/6 Alinity m SARS CoV2 AMP KIT
Alinity m SARS CoV2 CTRL KIT
Abbot Molecular Inc. Nucleic acid
36 2021/1/7 cobas SARS-CoV-2
cobas SARS-CoV-2 Control Kit
Roche Molecular Systems, Inc. Nucleic acid
37 2021/1/19 Virokey SARS CoV-2 RT PCR Test v2.0 Vela Operations Singapore Pte Ltd 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 Nucleic acid
39 2021/2/4 Elecsys Anti-SARS-CoV-2 Roche Diagnostics Gmbh 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. Antibody
41 2021/2/9 cobas SARS-CoV-2
cobas SARS-CoV-2 Control Kit
Roche Molecular Systems, Inc. Nucleic acid
42 2021/2/23 Xpert Xpress SARS-CoV-2 Cepheid Inc. 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 Antibody
44 2021/4/21 Alinity m Resp-4-Plex AMP Kit
Alinity m Resp-4-Plex CTRL Kit
Abbott Molecular Inc. Nucleic acid
45 2021/4/21 BioFire Respiratory Panel 2.1 (RP2.1) Biofire Diagnostics, LLC Nucleic acid
46 2021/4/30 QIAstat-Dx Operational Module
QIAstat-Dx Analytical Module
QIAstat-Dx Respiratory SARS-CoV-2 Panel
QIAGEN Gmbh Nucleic acid
47 2021/5/10 Panbio COVID-19 Ag Rapid Test Device (NASAL) Abbott Rapid Diagnostics Jena Gmbh Antigen
48 2021/5/17 cPass SARS-CoV-2 Neutralization Antibody Detection Kit Genscript USA,Inc. Antibody
49 2021/5/25 BD Veritor System for Rapid Detection of SARS-Cov-2 Becton, Dickinson And Company Antigen
50 2021/5/25 ID NOW COVID-19 Abbott Diagnostic Scarborough, Inc. Nucleic acid
51 2021/5/25 Panbio COVID-19 Ag Rapid Test Device (Nasopharyngeal) Abbott Rapid Diagnostics Jena Gmbh Antigen
52 2021/5/25 Panbio COVID-19 Ag Rapid Test Device (NASAL) Abbott Rapid Diagnostics Jena Gmbh 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 Nucleic acid
53-2 2021/6/24 MAGMAX Viral/Pathogen II Nucleic Acid Isolation Kit Thermo Fisher Scientific Baltics Uab Nucleic acid
54 2021/5/25 Alinity m SARS CoV2 AMP KIT
Alinity m SARS CoV2 CTRL KIT
Abbott Molecular Inc. Nucleic acid
55 2021/5/25 Xpert Xpress SARS-CoV2 Cepheid Inc. Nucleic acid
56 2021/5/26 SARS-CoV-2 Reagents for BD MAX System Becton Dikinson And Company 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. Nucleic acid
58 2021/5/28 Xpert Xpress SARS-CoV-2 Cepheid Inc. 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. Antibody
60 2021/6/7 SARS-CoV-2 Rapid Antigen Test Sd Biosensor, Inc. Antigen
61 2021/6/10 GenBody COVID-19 Ag Genbody Inc. 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. 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. Antigen
64 2021/6/11 Lucira CHECK-IT COVID-19 Test Kit Lucira Health, Inc. Nucleic acid
65 2021/6/11 Lucira CHECK- IT COVID-19 Test Kit Lucira Health, Inc. Nucleic acid
66 2021/6/11 ViroKey SARS-CoV-2 RT-PCR Test v2.0 Vela Operations Singapore Pte Ltd Nucleic acid
67 2021/6/11 SARS-CoV-2 Antigen Self Test Nasal Sd Biosensor, Inc Antigen
68 2021/6/18 STANDARD Q COVID-19 Ag
STANDARD F COVID-19 Ag FIA
Sd Biosensor, Inc. Antigen
69 2021/6/18 Elecsys Anti-SARS-CoV-2 Roche Diagnostics Gmbh Antibody
70 2021/6/21 BD Veritor System for Rapid Detection of SARS-CoV-2 Bd Rapid Diagnostic Suzhou Co Ltd 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 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 Antigen
73 2021/6/22 Biocode SARS-CoV-2 Assay Kit Applied Biocode, Inc 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 Antibody
75 2021/6/22 INNOSCREEN covid-19 Antigen Rapid Test Device Abbott Ireland Diagnostics Division Antigen
76 2021/6/23 Humasis COVID-19 Ag Test Humasis Co., Ltd. Antigen
77 2021/6/25 GenBody COVID-19 Ag Genbody Inc. Antigen
78 2021/6/28 EURORealTime SARS-CoV-2 Euroimmun Medizinische Labordiagnostika Ag Nucleic acid
79 2021/6/29 MassARRAY SARS-CoV-2 Panel Agena Bioscience, Inc. 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 Nucleic acid
81 2021/6/29 GenBody COVID-19 Ag Genbody Inc. Antigen
82 2021/7/1 InteliSwab COVID-19 Rapid Test Orasure Technologies, Inc. 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 Antibody
84 2021/7/2 cPass SARS-CoV-2 Neutralization Antibody Detection Kit Genscript USA Inc. 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. Antibody
86 2021/7/5 CareStart COVID-19 Antigen Access Bio Antigen
87 2021/7/7 Anti-SARS-CoV-2 ELISA (IgG) Euroimmun Medizinische Labordiagnostika Ag Antibody
88 2021/7/8 Panbio COVID-19 Antigen SELF-TEST Abbott Rapid Diagnostics Jena Gmbh Antigen
89  2021/7/8 INNOSCREEN COVID-19 IgG/IgM Rapid Test Device Innovation Scientific Pty Ltd Antibody
90 2021/7/8 QuickVue SARS Antigen Test Quidel Corporation Antigen
91 2021/7/8 COVID-19 IgG/IgM Rapid Test Cassette Hangzhou Clongene Biotech Co., Ltd. Antibody
92 2021/7/13 STANDARD Q COVID-19 Ag Home Test SD Biosensor Inc. 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 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 Antibody
95 2021/7/14 Biocredit COVID-19 Ag RapiGEN Inc Antigen
96 2021/7/19 Humasis COVID-19 Ag Home test Humasis Co., Ltd. Antigen
97 2021/7/22 DiaPlexQ Novel coronavirus (2019-nCoV) Detection Kit Solgent Co.,Ltd Nucleic acid
98 2021/7/26 Sofia SARS Antigen FIA QUIDEL CORPORATION Antigen
99 2021/7/27 Humasis COVID-19 Ag Test Humasis Co., Ltd. Antigen
100 2021/7/28 BIOCREDIT COVID-19 Ag Home Test Nasal RapiGEN INC Antigen
101 2021/7/28 SGTi-flex COVID-19 IgM/IgG Sugentech, Inc. 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. Antibody
103 2021/7/29 Humasis COVID-19 Ag Home test Humasis Co.,Ltd Antigen
104 2021/7/30 QuantiVirus SARS-CoV-2 Test Kit DiaCarta, Inc. 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 Antibody
106 2021/8/3 BIOCREDIT COVID-19 Ag Home Test Nasal RapiGEN INC Antigen
107 2021/8/4 DiaPlexQ Novel Coronavirus (2019 nCoV) Detection Kit Solgent Co.,Ltd Nucleic acid
108 2021/8/4 STANDARD Q COVID-19 IgM/IgG Plus
STANDARD F COVID-19 IgM/IgG Combo FIA
SD BIOSENSOR, INC. Antibody
109 2021/8/5 Celltrion DiaTrust COVID-19 Ag Home Test Humasis Co., Ltd. Antigen
110 2021/8/9 STANDARD Q COVID-19 Ag Test SD Biosensor,Inc. Antigen
111 2021/8/10 Celltrion DiaTrust COVID-19 Ag Home Test Kit Humasis Co., Ltd. Antigen
112 2021/8/30 BIOCREDIT COVID-19 Ag Home Test Nasal RapiGEN INC Antigen
113 2021/8/30 SARS-CoV-2 Rapid Antigen Test Nasal SD BIOSENSOR, INC. Antigen
114 2021/8/30 Humasis COVID-19 Ag Test Humasis Co., Ltd. Antigen
115 2021/9/14 Advanta Dx SARS-CoV-2 RT-PCR Assay Fluidigm Corporation Nucleic acid
116 2021/9/14 TaqPath COVID-19 Fast PCR Combo Kit 2.0 Life Technologies Corporation 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) Antigen
118 2021/9/15 BD SARS-CoV-2/Flu for BD MAX System BECTON,DICKINSON AND COMPANY Nucleic acid
119 2021/9/23 CareStart COVID-19 Antigen Access Bio, Inc. 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 Nucleic acid
121 2021/10/7 SARS-CoV-2 NGS ASSAY Twist Bioscience Corporation    Nucleic acid
122 2021/10/7 VERI-Q Covid-19 Ag Rapid Test MiCoBioMed Co.,Ltd Antigen
123 2020/10/25 cPASSTM SARS-CoV-2 Neutralization Antibody Detection Kit GenScript USA,Inc Antibody
124 2021/10/26 CovAb SARS-CoV-2 Ab Test Diabetomics, Inc. Antibody
125 2021/11/2 Flowflex COVID-19 Antigen Home Test ACON Laboratories, Inc. Antigen
126 2021/11/3 GenBody COVID-19 Ag Home Test GenBody Inc. Antigen
127 2021/11/4 “ASAN”Easy Test COVID-19 Ag Asan Pharmaceutical CO.,LTD. Antigen
128 2021/11/9 VERI-Q COVID-19 Ag Rapid Test ERA BIOTEQ ENTERPRISE CO., LTD. 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 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 Antibody
131 2021/12/30 Alinity m SARS-CoV-2 AMP kit
Alinity m SARS-CoV-2 CTRL kit
Abbot Molecular Inc. Nucleic acid
132 2022/2/09 Xpert Xpress SARS-CoV-2 Cepheid Inc. Nucleic acid
133 2022/2/15 GenBody COVID-19 Ag Home Test GENBODY INC. Antigen
134 2022/3/4 Humasis COVID-19 Ag Test Humasis Co., Ltd. Antigen
135 2022/3/28 BioCode CoV-2 Flu Plus assay Applied Biocode, Inc. Nucleic acid
136 2022/3/28 Aptima SARS-CoV-2 Assay Kit Hologic,Inc. Nucleic acid
137 2022/4/18 Virokey SARS CoV-2 RT PCR Test v2.0 Vela Operations Singapore Pte Ltd Nucleic acid
138 2022/4/19 Allplex 2019-nCoV Assay Seegene Inc. Nucleic acid
139 2022/4/21 GenBody COVID-19 Ag Home Test GENBODY INC. Antigen
140 2022/4/28 GenBody COVID-19 Ag GenBody Inc. Antigen
141 2022/4/29 Gmate COVID-19 Ag Saliva Philosys Co.,Ltd Antigen
142 2022/5/3 BD kit for rapid detection of SARS-CoV-2 BD Rapid Diagnostics (Suzhou) Co., Ltd. Antigen
143 2022/5/6 Humasis COVID-19 Ag Test Humasis Co., Ltd. Antigen
144 2022/5/9 BIOCREDIT COVID-19 Ag Home Test Nasal RapiGEN INC. Antigen
145 2022/5/10 Flowflex COVID-19 Antigen Home Test ACON Laboratories, Inc. Antigen
146 2022/5/10 Humasis COVID-19 Ag Home Test Humasis Co., Ltd. Antigen
147 2022/5/12 Panbio COVID-19 Ag Rapid Test Device (NASAL) Abbott Rapid Diagnostics Jena GmbH Antigen
148 2022/5/13 InnoScreen COVID-19 Antigen Rapid Test Device (Self-Test) INNOVATION SCIENTIFIC PTY LTD Antigen
149 2022/5/13 Indicaid covid-19 rapid antigen at-home test Phase Scientific International Limited Antigen
150 2022/5/13 Panbio COVID-19 Ag Rapid Test Device(Nasopharyngeal) Abbott Rapid Diagnostics Jena GmbH Antigen
151 2022/5/16 Xpert Xpress SARS-CoV-2 CEPHEID Nucleic acid
152 2022/5/20 Humasis COVID-19 Ag Home test Humasis Co.,Ltd Antigen
153 2022/5/20 STANDARD Q COVID-19 Ag Home Test SD BIOSENSOR, INC. Antigen
154 2022/5/20 STANDARD Q COVID-19 Ag Home Test SD Biosensor, Inc. Antigen
155 2022/5/20 InnoScreen COVID-19 Antigen Rapid Test Device Innovation Scientific Pty Ltd Antigen
156 2022/5/20 DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit SolGent Co., Ltd Nucleic acid
157 2022/5/23 PCL SELF TEST-COVID19 Ag PCL, Inc Antigen
158 2022/5/23 INDICAID COVID-19 Rapid Antigen At-home test PHASE Scientific International Ltd. Antigen
  • Created:2021-10-25
  • Last Updated:2022-05-26
  • Data Source:Department of Information Management
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