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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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)
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