Links to the lists of vaccines or tests
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 |
5 | Novavax | 2022/06/22 |
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 |
71 | 2022/5/25 | Vstrip COVID-19 S-RBD Antibody Rapid Test | Panion & BF Biotech Inc. Xizhi Factory | Antibody |
72 | 2022/6/13 2022/8/15 |
Ainos SARS-CoV-2 Antigen Rapid Self Test | Taiwan Carbon Nano Technology Corporation | Antigen |
73 | 2022/6/13 | Swiscare COVID-19 Antigen Self-Testing Kit | Swiscare Technology Co., Ltd | Antigen |
74 | 2022/8/2 | SBC COVID-19 IgG ELISA Kit | Manufactured by ACCUBIOMED CO., LTD. for SCHWEITZER BIOTECH COMPANY LTD. | Antibody |
75 | 2022/8/16 | GENEONE COVID-19 Nucleic Acid Diagnostic Kit | GeneOne Diagnostics Corporation | Nucleic acid |
76 | 2022/9/28 | PixoTest COVID-19 Antigen Self Test Kit | iXensor Co., LTD. Neihu Factory | Antigen |
77 | 2022/10/4 | ETERNAL SARS-CoV-2 SRBD Antibody Rapid Test | ETERNAL MATERIALS CO., LTD. Xizhi Plant. | Antibody |
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 ~2022/8/22 |
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 |
159 | 2022/5/25 | DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit | SolGent Co., Ltd. | 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. | Antibody |
161 | 2022/6/6 | PCL SELF TEST-COVID19 Ag | PCL,Inc. | Antigen |
162 | 2022/6/8 | VERI-Q COVID-19 Ag Rapid Test | MiCo BioMed Co., Ltd | Antigen |
163 | 2022/6/10 | Rapid ResponseTM COVID-19 Antigen Rapid Test Cassette - At Home | BTNX, INC. | Antigen |
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. | Nucleic acid |
165 | 2022/6/10 | BIOCREDIT COVID-19 Ag Home Test Nasal | RapiGEN, Inc. | Antigen |
166 | 2022/8/9 | PCL SELF TEST COVID19 Ag | PCL Inc. | 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 |
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 |
Nucleic acid |
169 | 2022/8/18 | obas SARS-CoV-2 Duo cobas SARS-CoV-2 Duo Control Kit |
Roche Molecular Systems, Inc. | Nucleic acid |
170 | 2022/8/18 | Xpert Xpress CoV-2 plus | Cepheid | Nucleic acid |
171 | 2022/8/18 | cobas SARS-CoV-2 cobas SARS-CoV-2 Control Kit |
Roche Molecular Systems, Inc. | 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 |
Nucleic acid |
173 | 2022/8/19 | PCL SELF TEST-COVID19 Ag | PCL,Inc. | Antigen |
174 | 2022/8/19 | PCL SELF TEST COVID19 Ag | PCL,Inc. | Antigen |
175 | 2022/8/23 | PCL SELF TEST COVID19 Ag | PCL,Inc. | Antigen |
176 | 2022/8/24 | ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | Nucleic acid |
177 | 2022/8/30 | PCL SELF TESTCOVID19 Ag | PCL,Inc. | Antigen |
178 | 2022/9/13 | BioFire Respiratory Panel 2.1 (RP2.1) | BioFire Diagnostic, LLC | Nucleic acid |
179 | 2022/9/16 | Xpert Xpress SARS-CoV-2 /Flu/RSV plus | Cepheid | Nucleic acid |
180 | 2022/10/5 | STANDARD M10 SARS-CoV-2 STANDARD M10 |
SD Biosensor, Inc. | Nucleic acid |
- Created:2021-10-25
- Last Updated:2022-10-13
- Data Source:Department of Information Management
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