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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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Light Diagnostics ™ Influenza A Monoclonal Antibody - 04053252470226

Influenza A Monoclonal Antibody
EMD Millipore Corporation
5001
Not in Commercial Distribution

  • 04053252470226 ()
5001

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

Light Diagnostics ™ Coxsackievirus B4 Monoclonal Antibody - 04053252408489

Coxsackievirus B4 Monoclonal Antibody
EMD Millipore Corporation
3307
Not in Commercial Distribution

  • 04053252408489 ()
3307

  • Coxsackie A/B virus antigen IVD, reagent

HemosIL Routine Control Level 3 - 08426950573401

HemosIL Routine Control Level 3
INSTRUMENTATION LABORATORY COMPANY
00020005800
In Commercial Distribution

  • 08426950573401 ()
  • 18426950573408 ()
00020005800

  • Multiple coagulation factor IVD, control

HemosIL Routine Control Level 2 - 08426950573395

HemosIL Routine Control Level 2
INSTRUMENTATION LABORATORY COMPANY
00020005700
In Commercial Distribution

  • 08426950573395 ()
  • 18426950573392 ()
00020005700

  • Multiple coagulation factor IVD, control

HemosIL Routine Control Level 1 - 08426950573388

HemosIL Routine Control Level 1
INSTRUMENTATION LABORATORY COMPANY
00020005600
In Commercial Distribution

  • 08426950573388 ()
  • 18426950573385 ()
00020005600

  • Multiple coagulation factor IVD, control

HemosIL UF Heparin Controls - 08426950478683

HemosIL UF Heparin Controls
INSTRUMENTATION LABORATORY COMPANY
00020300300
In Commercial Distribution

  • 08426950478683 ()
  • 18426950478680 ()
00020300300

  • Heparin anti-Xa IVD, control

HemosIL Factor XIII Antigen - 08426950358725

HemosIL Factor XIII Antigen
INSTRUMENTATION LABORATORY COMPANY
00020201300
In Commercial Distribution

  • 08426950358725 ()
00020201300

  • Coagulation factor XIII A subunit IVD, kit, nephelometry/turbidimetry

VITROS - 10758750008926

VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator
ORTHO CLINICAL DIAGNOSTICS
1372101
In Commercial Distribution

  • 10758750008926 ()
  • 20758750008923 ()
1372101

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750001477

VITROS Immunodiagnostic Products HAV Total Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801823
In Commercial Distribution

  • 10758750001477 ()
  • 20758750001474 ()
6801823

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750001415

VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801812
In Commercial Distribution

  • 10758750001415 ()
  • 20758750001412 ()
6801812

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
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