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Intended to be used for the qualitative detection of RNA from SARS-CoV-2
Fast- profile 96 well PCR plated assay and optical film for use on ABI 7500 Fast instrument .
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution
- 05060654860127 ()
- 05060654860080 ()
ID-CoV2-01-FPU
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Intended to be used for the qualitative detection of RNA from SARS-CoV-2
Low profile 96 well PCR plated assay and optical film for use on Biorad CFX96 instrument.
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution
- 05060654860103 ()
- 05060654860110 ()
ID-CoV2-01-BPU
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
The Accula™ SARS-Cov-2 Test performed on the Accula™ Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The Accula SARS-CoV-2 Test uses a throat swab and nasal swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.
MESA BIOTECH, INC.
COV4100
In Commercial Distribution
- B540COV41000 ()
COV4100
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
EUA
INBIOS INTERNATIONAL, INC
COV2-E
In Commercial Distribution
- B379COV2E0 ()
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199976
In Commercial Distribution
- 10758750034581 ()
6199976
- SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199975
In Commercial Distribution
- 10758750034567 ()
6199975
- SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199923
In Commercial Distribution
- 10758750033393 ()
6199923
- SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6199922
In Commercial Distribution
- 10758750033386 ()
6199922
- SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
No Description
Neumodx Molecular, Inc.
300800
In Commercial Distribution
- 00814278021267 ()
- 10814278021264 ()
300800
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
MP 2606-0200
In Commercial Distribution
- 04049016145745 ()
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)