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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 - 10758750034420

VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199961
In Commercial Distribution

  • 10758750034420 ()
6199961

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750034413

VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6199960
In Commercial Distribution

  • 10758750034413 ()
6199960

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750033591

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199950
In Commercial Distribution

  • 10758750033591 ()
6199950

  • SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay

VITROS - 10758750033584

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199949
In Commercial Distribution

  • 10758750033584 ()
6199949

  • SARS-CoV-2 antigen IVD, kit, chemiluminescent immunoassay

VITROS - 10758750033577

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Extraction Buffer
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199944
In Commercial Distribution

  • 10758750033577 ()
6199944

  • Clinical specimen extraction buffer IVD

VITROS - 10758750033560

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Controls
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199943
In Commercial Distribution

  • 10758750033560 ()
6199943

  • SARS-CoV-2 antigen IVD, control

VITROS - 10758750033393

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 - 10758750033386

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

VITROS - 10758750033379

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls
ORTHO CLINICAL DIAGNOSTICS
6199921
In Commercial Distribution

  • 10758750033379 ()
6199921

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

VITROS - 10758750033362

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199920
In Commercial Distribution

  • 10758750033362 ()
6199920

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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