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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 - 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

VITROS - 10758750033355

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6199919
In Commercial Distribution

  • 10758750033355 ()
6199919

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

ORTHO - 10758750013265

ORTHO VERSEIA™ Pipetter
ORTHO-CLINICAL DIAGNOSTICS, INC.
5561701
In Commercial Distribution

  • 10758750013265 ()
5561701

  • Enzyme immunoassay (EIA) analyser IVD

ORTHO - 10758750011599

ORTHO VERSEIA™ Pipetter Workstation - monitor, accessories
ORTHO-CLINICAL DIAGNOSTICS, INC.
6842852B
In Commercial Distribution

  • 10758750011599 ()
6842852B

  • Enzyme immunoassay (EIA) analyser IVD

ORTHO - 10758750007523

Auto Reader IV
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902093
In Commercial Distribution

  • 10758750007523 ()
6902093

  • Microplate reader IVD, automated/semi-automated
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