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

  • 10758750033560 ()
6199943

  • SARS-CoV-2 antigen IVD, control
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
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 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 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 VERSEIA™ Pipetter
ORTHO-CLINICAL DIAGNOSTICS, INC.
5561701
In Commercial Distribution

  • 10758750013265 ()
5561701

  • Enzyme immunoassay (EIA) analyser IVD
OAS Server for VERSEIA Integrated Processor (VIP)
ORTHO-CLINICAL DIAGNOSTICS, INC.
6842840
In Commercial Distribution

  • 10758750012763 ()
6842840

  • Laboratory instrument/analyser application software IVD
ORTHO VERSEIA™ Pipetter Workstation - monitor, accessories
ORTHO-CLINICAL DIAGNOSTICS, INC.
6842852B
In Commercial Distribution

  • 10758750011599 ()
6842852B

  • Enzyme immunoassay (EIA) analyser IVD
ORTHO VERSEIA™ Pipetter Workstation - computer
ORTHO-CLINICAL DIAGNOSTICS, INC.
6842852
In Commercial Distribution

  • 10758750011582 ()
6842852

  • Enzyme immunoassay (EIA) analyser IVD
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