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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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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

Hevylite® Human IgA Kappa Kit for use on the SPAPLUS - 05051700017985

No Description
THE BINDING SITE GROUP LIMITED
NK623.S.A
In Commercial Distribution

  • 05051700017985 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Atellica IM aHAVT - 00630414301297

HAV Total Ab (aHAVT) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207271
In Commercial Distribution

  • 00630414301297 ()
11207271

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

Atellica IM aHAVM - 00630414301259

HAV IgM Ab (aHAVM) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11207243
In Commercial Distribution

  • 00630414301259 ()
11207243

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

Optilite Hevylite® IgA Kappa Kit - 05051700018487

No Description
THE BINDING SITE GROUP LIMITED
NK623.OPT.A
In Commercial Distribution

  • 05051700018487 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

MONOLISA - 00847865012379

MONOLISA Anti-HAV IgM EIA
BIO-RAD
72495
In Commercial Distribution

  • 00847865012379 ()
72495

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

MONOLISA - 00847865012362

MONOLISA Anti-HAV EIA
BIO-RAD
72496
In Commercial Distribution

  • 00847865012362 ()
72496

  • Hepatitis A virus total antibody IVD, kit, enzyme immunoassay (EIA)

Atellica IM aHAVT QC - 00630414597775

HAV Total (HAVT) QC Kit - Atellica IM - CTL 2 x 2 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10995447
In Commercial Distribution

  • 00630414597775 ()
10995447

  • Hepatitis A virus total antibody IVD, control
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