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

  • 10758750007523 ()
6902093

  • Microplate reader IVD, automated/semi-automated
FETALSCREEN™ is a Qualitative Screening Test for RhD (Rho) positive fetal red blood cells in the maternal circulation.
ALBA BIOSCIENCE LIMITED
Z488
In Commercial Distribution

  • 10758750006144 ()


  • Foeto-maternal haemorrhage/Kleihauer test IVD, control
Ortho Summit Processor (OSP)
ORTHO-CLINICAL DIAGNOSTICS, INC.
936480
In Commercial Distribution

  • 10758750005581 ()
936480

  • Enzyme immunoassay (EIA) analyser IVD
OAS Server - 450 MHz, Refurbished
ORTHO-CLINICAL DIAGNOSTICS, INC.
936416F
In Commercial Distribution

  • 10758750005505 ()
936416F

  • Laboratory instrument/analyser application software IVD
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