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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 ™ SimulFluor® Flu A/Flu B Reagent - 04053252368165

SimulFluor® Flu A/Flu B Reagent
EMD Millipore Corporation
5250
Not in Commercial Distribution

  • 04053252368165 ()
5250

  • Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA)

Light Diagnostics ™ SimulFluor® Flu A / Flu B Reagent - 04053252270239

SimulFluor® Flu A / Flu B Reagent
EMD Millipore Corporation
5250-5ML
Not in Commercial Distribution

  • 04053252270239 ()
5250-5ML

  • Multiple-genus respiratory virus antigen IVD, kit, enzyme immunoassay (EIA)

ARCHITECT - 00380740011093

ARCHITECT HAVAB-M Reagent Kit
Abbott GmbH
6L21-25
In Commercial Distribution

  • 00380740011093 ()
06L2125

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

ARCHITECT - 00380740011086

ARCHITECT HAVAB-M Controls
Abbott GmbH
6L21-10
In Commercial Distribution

  • 00380740011086 ()
06L2110

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control

ARCHITECT - 00380740011079

ARCHITECT HAVAB-M Calibrator
Abbott GmbH
6L21-01
In Commercial Distribution

  • 00380740011079 ()
06L2101

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, calibrator

Alinity - 00380740136628

Alinity i HAVAb IgM Reagent Kit 1000 Tests
Abbott GmbH
08P2831
In Commercial Distribution

  • 00380740136628 ()
08P2831

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

Alinity - 00380740136611

Alinity i HAVAb IgM Reagent Kit 200 Tests
Abbott GmbH
08P2821
In Commercial Distribution

  • 00380740136611 ()
08P2821

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

Alinity - 00380740131579

Alinity i HAVAb IgM Controls
Abbott GmbH
08P2810
In Commercial Distribution

  • 00380740131579 ()
08P2810

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control

Alinity - 00380740197650

HAVAb IgG II Reagent Kit 200 test
Abbott GmbH
06S9321
In Commercial Distribution

  • 00380740197650 ()
06S9321

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

Alinity - 00380740131562

Alinity i HAVAb IgM Calibrator
Abbott GmbH
08P2801
In Commercial Distribution

  • 00380740131562 ()
08P2801

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, calibrator
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