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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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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
Chemical indicator strip for monitoring hydrogen peroxide sterilization processes.
TERRAGENE S.A.
CD40
In Commercial Distribution

  • 07798164676843 ()
  • 07798164672142 ()


  • Chemical/physical sterilization process indicator
Chemical indicator strip for monitoring hydrogen peroxide sterilization processes.
TERRAGENE S.A.
CD40
In Commercial Distribution

  • 07798164676843 ()
  • 07798164672135 ()


  • Chemical/physical sterilization process indicator
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
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
VITROS Immunodiagnostic Products Anti-HAV Total Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801462
In Commercial Distribution

  • 10758750001286 ()
  • 20758750001283 ()
6801462

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07026757190
In Commercial Distribution

  • 04015630939916 ()
07026757190

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