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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 - 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 - 10758750033294

VITROS Immunodiagnostic Products BRAHMS PCT Calibrator
ORTHO CLINICAL DIAGNOSTICS
6195575
In Commercial Distribution

  • 10758750033294 ()
  • 20758750033291 ()
6195575

  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750033171

VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen)
ORTHO CLINICAL DIAGNOSTICS
691 2263
In Commercial Distribution

  • 10758750033171 ()
  • 20758750033178 ()
691 2263

  • HIV1 antigen IVD, control

VITROS - 10758750002528

VITROS Immunodiagnostic Products Troponin I ES Range Verifiers
ORTHO CLINICAL DIAGNOSTICS
6802303
In Commercial Distribution

  • 10758750002528 ()
  • 20758750002525 ()
6802303

  • Troponin I IVD, kit, chemiluminescent immunoassay

InteliQ - 03610522354665

InteliQ Specialty Immunoassay Plus Control Level Low MiniPak (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12019558
In Commercial Distribution

  • 03610522354665 ()
12019558

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610522354658

Liquichek Specialty Immunoassay Plus Control Level Low MiniPak (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12019576
In Commercial Distribution

  • 03610522354658 ()
12019576

  • Multiple clinical chemistry protein IVD, control

Exact Diagnostics - 03610522350773

Bulk CSF Negative
EXACT DIAGNOSTICS, LLC
12019432
In Commercial Distribution

  • 03610522350773 ()
12019432

  • PCR/NAT negative control IVD

InteliQ - 03610522248902

InteliQ Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016487
In Commercial Distribution

  • 03610522248902 ()
12016487

  • Multiple cardiac marker IVD, control

InteliQ - 03610522248896

InteliQ Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016486
In Commercial Distribution

  • 03610522248896 ()
12016486

  • Multiple cardiac marker IVD, control

InteliQ - 03610522248889

InteliQ Cardiac Advance Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016485
In Commercial Distribution

  • 03610522248889 ()
12016485

  • Multiple cardiac marker IVD, control
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