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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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Alinity - 00380740131371

Alinity i HAVAb IgG Reagent Kit 200 Tests
Abbott GmbH
08P2721
In Commercial Distribution

  • 00380740131371 ()
08P2721

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Light Diagnostics™ Influenza A and B DFA Kit - 08436037124594

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)

Influenza Virus B IgG ELISA - 00840239037961

The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3796
In Commercial Distribution

  • 00840239037961 ()
EIA-3796

  • Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Influenza Virus A IgG ELISA - 00840239037930

The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3793
In Commercial Distribution

  • 00840239037930 ()
EIA-3793

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

SEEKER™ - 00819704020111

SEEKER™ GLA Reagent (alpha-D-galactosidase)
BAEBIES, INC.
1202
In Commercial Distribution

  • 00819704020111 ()
1202

  • Newborn metabolic screen/congenital disorder IVD, reagent

Elecsys Anti-HAV - 04015630939916

No Description
Roche Diagnostics GmbH
07026757190
In Commercial Distribution

  • 04015630939916 ()
07026757190

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

Elecsys Anti-HAV IgM - 04015630939855

No Description
Roche Diagnostics GmbH
07026773190
In Commercial Distribution

  • 04015630939855 ()
07026773190

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

Elecsys AntiHAV IgM - 04015630938858

No Description
Roche Diagnostics GmbH
11820591160
In Commercial Distribution

  • 04015630938858 ()
11820591160

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

Elecsys AntiHAV Assay - 04015630938841

No Description
Roche Diagnostics GmbH
5524261160
In Commercial Distribution

  • 04015630938841 ()
5524261160

  • Hepatitis A virus antigen IVD, kit, chemiluminescent immunoassay

Chemdye® - 07798164672142

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

  • 07798164676843 ()
  • 07798164672142 ()


  • Chemical/physical sterilization process indicator
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