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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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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)
Alinity s Concentrated Wash Buffer
Abbott Ireland Diagnostics
06P1388
In Commercial Distribution

  • 00380740118181 ()
06P1388

  • Buffered wash solution IVD
No Description
EUROIMMUN Medizinische Labordiagnostika AG
MP 2606-0200
In Commercial Distribution

  • 04049016145745 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
MP 2606-0100
In Commercial Distribution

  • 04049016145691 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
MP 2606-0425
In Commercial Distribution

  • 04049016145660 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
MP 2606-0225
In Commercial Distribution

  • 04049016145653 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
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