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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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Status™ COVID-19 Antigen Rapid Test for Home Use - 10743816001645

Status™ COVID-19 Antigen for Home Use, 25 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-512-25-00
In Commercial Distribution

  • 10743816001645 ()
BSP-512-025-00

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Status™ COVID-19 Antigen Rapid Test for Home Use - 10743816001638

Status™ COVID-19 Antigen Rapid Test for Home Use, 2 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-512-02-00
In Commercial Distribution

  • 10743816001638 ()
BSP-512-02-00

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Status™ COVID-19 Antigen Rapid Test for Home Use - 10743816001621

Status™ COVID-19 Antigen Rapid Test for Home Use, 1 Test Kit
PRINCETON BIOMEDITECH CORPORATION
BSP-512-01-00
In Commercial Distribution

  • 10743816001621 ()
BSP-512-01-00

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

First Aid Kit - 08052691610008

First Aid Kit for car makers, to be placed into vehicles
Tek Corporation
DIN-131642022-02
In Commercial Distribution

  • 08052691610008 ()
  • 08052691610015 ()
  • 08052691610022 ()
  • 08052691610039 ()


  • Medical bag

LEADER - 00096295144857

LDR First Aid Kit All-purpose 140 pieces
Cardinal Health 110, Inc.
5956727
In Commercial Distribution

  • 60096295144859 ()
  • 00096295144857 ()
5956727

  • First aid kit, medicated

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 - 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

ORTHO - 10758750007523

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

  • 10758750007523 ()
6902093

  • Microplate reader IVD, automated/semi-automated

FETALSCREEN™II - 10758750006144

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 - 10758750005581

Ortho Summit Processor (OSP)
ORTHO-CLINICAL DIAGNOSTICS, INC.
936480
In Commercial Distribution

  • 10758750005581 ()
936480

  • Enzyme immunoassay (EIA) analyser IVD
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