Gentaur Sopot Testy SARS-CoV-2

przez | 17 listopada, 2020

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

PCR are

Vials with samples of SARS-COV-1 in a research laboratory, conceptual image


  1. 3DMed 2019-nCoV qRT-PCR detection kit 3103010011 3D Biomedicine Science & Technology Co., Ltd.  
  2. COVID-19 VERI-Q PCR 316 7K105 Detection System MiCo BioMed Co., Ltd. R 
  3. Bio-Speedy SARS-COV2 (2019-nCoV) Kit for qPCR detection BS-SY-WCOR-303-100 Bioeksen R&D Technologies Ltd.  
  4. SARS-CoV-2 (ORF1ab / N) Kit for the detection of nucleic acids (fluorescent PCR
  5. Sonda) SUPI-2501 Guangzhou Supbio Bio-technology and Science Co., Ltd  
  6. COVID-19 (SARS-CoV-2) nCOV-PCR-02-100B Nucleic Acid Test Kit Wuhan EasyDiagnosis Biomedicine Co., Ltd.  R.
  7. SAMBA II SARS-CoV-2 Test 8500-12 Diagnostics Real World Ltd awaiting notification awaiting submission
  8. Wondfo SARS-CoV-2 Real-Time RT PCR assay W275P0009, W275P0010,
  9. W275P0011 i W275P0012. Guangzhou Wondfo Biotech Co., Ltd.  
  10. COVID-19 RADI RV008 KH Medical Co., Ltd detection kit  
  11. SarbecoV E-gen EAV 40-0776-96 TIB MOLBIOL Syntheselabor GmbH R awaiting submission
  12. Zestaw Genedrive 96 SARS-CoV2 ID-CoV2-01-LPC Genedrive Diagnostics Ltd  
  13. New Coronavirus 2019 (2019-nCoV) Triplex RT-qPCR CD302-02 Detection Kit Medical Technology Nanjing Vazyme Company.  
  14. Test Allplex SARS-CoV-2 RV10248X and RV10247Y Seegene Inc.  
  15. PowerCheck SARS-CoV-2 kit for real-time PCR IR6902 Kogene Biotech Co., Ltd  R
  16. QuantuMDx SARS-CoV-2 RT-PCR Detection Assay Q22003 QuantuMDx Group Ltd  
  17. 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


Cliamedical worker in rubber gloves putting test tube rack with blood samples while using laboratory machine for blood research


  1. ESPLINE SARS-CoV-2 231906 Fujirebio, Inc. R 
  2. BIOEASY Diagnostic kit for SARS-CoV-2 Ag (Fluorescence
  3. Test immunochromatograficzny)
  4. YRLF04401025,
  5. YRLF04401050 i
  6. YRLF04401100
  7. Shenzhen Bioeasy Biotechnology Co., Ltd is awaiting your notification and awaiting your submission
  8. LumiraDx SARS-CoV-2 Ag L0160001nnxxx test LumiraDx UK Ltd awaiting notification awaiting sending
  9. SARS-CoV-2 rapid antigen test 9327592190 Roche Diagnostics GmbH  
  10. 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


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) 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
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  

igg test

COVID19 Antibody Test. Woman Using Pipette to Take Blood Sample for Rapid Test for Corona Virus.

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