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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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EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601 A
Not in Commercial Distribution

  • 04049016028284 ()


  • Influenza A virus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Influenza A and B DFA Kit
EMD Millipore Corporation
3123
Not in Commercial Distribution

  • 08436037124594 ()
3123

  • Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA)
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
INSTRUMENTATION LABORATORY COMPANY
00020005700
In Commercial Distribution

  • 08426950573395 ()
  • 18426950573392 ()
00020005700

  • Multiple coagulation factor IVD, control
HemosIL Routine Control Level 1
INSTRUMENTATION LABORATORY COMPANY
00020005600
In Commercial Distribution

  • 08426950573388 ()
  • 18426950573385 ()
00020005600

  • Multiple coagulation factor IVD, control
HemosIL UF Heparin Controls
INSTRUMENTATION LABORATORY COMPANY
00020300300
In Commercial Distribution

  • 08426950478683 ()
  • 18426950478680 ()
00020300300

  • Heparin anti-Xa IVD, control
HemosIL Factor XIII Antigen
INSTRUMENTATION LABORATORY COMPANY
00020201300
In Commercial Distribution

  • 08426950358725 ()
00020201300

  • Coagulation factor XIII A subunit IVD, kit, nephelometry/turbidimetry
SEEKER™ GLA Reagent (alpha-D-galactosidase)
BAEBIES, INC.
1202
In Commercial Distribution

  • 00819704020111 ()
1202

  • Newborn metabolic screen/congenital disorder IVD, reagent
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 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
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