SARS-CoV-2 Nucleic Acid Tests: Active Use Progress in the Emergency Use Inventory Assessment Process
Product Name Product Code (s) Manufacturer Name Document Review QMS
Estimate
- 3DMed 2019-nCoV qRT-PCR detection kit 3103010011 3D Biomedicine Science & Technology Co., Ltd.
- COVID-19 VERI-Q PCR 316 7K105 Detection System MiCo BioMed Co., Ltd. R
- Bio-Speedy SARS-COV2 (2019-nCoV) Kit for qPCR detection BS-SY-WCOR-303-100 Bioeksen R&D Technologies Ltd.
- SARS-CoV-2 (ORF1ab / N) Kit for the detection of nucleic acids (fluorescent PCR
- Sonda) SUPI-2501 Guangzhou Supbio Bio-technology and Science Co., Ltd
- COVID-19 (SARS-CoV-2) nCOV-PCR-02-100B Nucleic Acid Test Kit Wuhan EasyDiagnosis Biomedicine Co., Ltd. R.
- SAMBA II SARS-CoV-2 Test 8500-12 Diagnostics Real World Ltd awaiting notification awaiting submission
- Wondfo SARS-CoV-2 Real-Time RT PCR assay W275P0009, W275P0010,
- W275P0011 i W275P0012. Guangzhou Wondfo Biotech Co., Ltd.
- COVID-19 RADI RV008 KH Medical Co., Ltd detection kit
- SarbecoV E-gen EAV 40-0776-96 TIB MOLBIOL Syntheselabor GmbH R awaiting submission
- Zestaw Genedrive 96 SARS-CoV2 ID-CoV2-01-LPC Genedrive Diagnostics Ltd
- New Coronavirus 2019 (2019-nCoV) Triplex RT-qPCR CD302-02 Detection Kit Medical Technology Nanjing Vazyme Company.
- Test Allplex SARS-CoV-2 RV10248X and RV10247Y Seegene Inc.
- PowerCheck SARS-CoV-2 kit for real-time PCR IR6902 Kogene Biotech Co., Ltd R
- QuantuMDx SARS-CoV-2 RT-PCR Detection Assay Q22003 QuantuMDx Group Ltd
- New Coronavirus Nucleic Acid Diagnostic Kit (2019-nCoV) (PCR-Fluoresce S3107E24 and S3107E48 Sansure Biotech Inc
SARS-CoV-2 Rapid Antigen Testing: Progress of Active Applications in the Emergency Use Inventory Assessment Process
Product Name Product Code (s) Manufacturer Name Documentation Review QMS
Estimate
- ESPLINE SARS-CoV-2 231906 Fujirebio, Inc. R
- BIOEASY Diagnostic kit for SARS-CoV-2 Ag (Fluorescence
- Test immunochromatograficzny)
- YRLF04401025,
- YRLF04401050 i
- YRLF04401100
- Shenzhen Bioeasy Biotechnology Co., Ltd is awaiting your notification and awaiting your submission
- LumiraDx SARS-CoV-2 Ag L0160001nnxxx test LumiraDx UK Ltd awaiting notification awaiting sending
- SARS-CoV-2 rapid antigen test 9327592190 Roche Diagnostics GmbH
- SARS-CoV-2 (Colloidal Gold) Antigen Rapid Test Kit G10313 JOYSBIO (Tianjin) Biotechnology CO., LTD Awaiting Shipment Awaiting Shipment
SARS-CoV-2 Antibody Testing: Progress of Active Applications in the Emergency Use List Assessment Process
Product Name Product Code (s) Manufacturer Name Documentation Review QMS
Estimate
2019-nCoV IgGIgM Rapid Test Cassette (Full BloodSerumPlasma) INCP-402B Hangzhou AllTest Biotech Co. Ltd. Waiting for application Waiting for application
Diagnostic kit for SARS-CoV-2 IgG / IgM antibodies (colloidal gold) R-423-20-C, R-423-25-C Shanghai Kehua Bioengineering Co., Ltd.
One-step test for presence of IgM / IgG antibodies in the new coronavirus (2019-nCoV)
(Colloidal gold) CG2057 Getein Biotech Inc.
SARS-CoV-2 IgM / IgG Antibody Test Kit (Colloidal Gold Method) 109.01.96.02 Biohit Healthcare (Hefei) Co., Ltd.
New Coronavirus Test Kit (2019-nCoV) IgG / IgM (Colloidal Gold) 52026069 Genrui Biotech Inc. waiting for the application awaits sending
Nice test! COV-2 -SARS CoV- 2 specific test kit IgM / IgG CV 10.01 Pharmact GmbH RR
Wondfo SARS-CoV-2 antibody test (lateral flow method) W195 Guangzhou Wondfo Biotech Co., Ltd
SARS-CoV rapid antibody test -2 (IgM / IgG) ITP16001-TC25 and ITP16002- TC25
InTec PRODUCTS, INC
Wantai SARS-CoV-2 WJ-2710 and WJ-2750 Rapid Antibody Test Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Elecsys Anti -SARS-CoV-2 Qualitative test for use on cobas
e 411/601/602/801
immunoanalizers 9203095190; 09203079190;
09216928190 Roche Diagnostics GmbH
COVID-19IgM / IgG Antibody Test A03-51-322 Artron Laboratories Inc.
New Coronavirus Rapid Test (2019-nCoV) ART20200630 Bioscience (Tianjin) Diagnostic Technology Co., Ltd Awaiting Report Pending Submission
New Coronavirus (2019-nCoV) IgM / IgG Antibody Rapid Test MGRT20200630 Bioscience (Tianjin) Diagnostic Technology Co., Ltd
Awaiting Report Mologic COVID-19 Blood Rapid Diagnostic Test IgA / IgG / IgM 11911125 Mologic
VivaDiag COVID-19 IgM / IgG Rapid Test VID35-08-011 VivaChek Biotech (Hangzhou) Co. Ltd R
DS-EIA-ANTI-SARS-CoV-2-G S-2382 / 1.1 RPC Diagnostic Systems, Ltd. R.
DS-EIA-ANTI-SARS-CoV-2 S-2372 / 1.1 RPC Diagnostic Systems, Ltd.
Wantai SARS-CoV-2 Ab ELISA WS-1096 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
MAKE SURE SARS-CoV-2 IgG / IgM Rapid Test 43140-020 MP Biomedical Asia Pacific Pte Ltd
Awaiting Report Awaiting Report JOYSBIO COVID-19 Rapid IgG / IgM Test Kit (Colloidal Gold) G10312 JOYSBIO (Tianjin) Biotechnology Co ., Ltd R
iFlash-SARS-CoV-2 IgG (iFlash-2019-nCoV IgG) C86095G SHENZHEN YHLO BIOTECH CO., LTD
Diagnostic Kit for New Coronavirus IgG Antibody (2019-nCoV) (
CLIA Magnetic Particle) GAM20200828 Bioscience (Tianjin) Diagnostic Technology Co