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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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GS - 00847865001823

Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 480 Tests
Bio-RAD Laboratories, Inc.
32591
In Commercial Distribution

  • 00847865001823 ()

  • 480 Tests
32591

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

IMMULITE®/IMMULITE®1000 Systems PSA PSA Sample Diluent - 00630414954196

PSA Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386994
In Commercial Distribution

  • 00630414954196 ()
LPSZ

  • Buffered sample diluent IVD

IMMULITE®/IMMULITE®1000 Systems AF AFP Sample Diluent - 00630414953519

AF AFP Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387015
In Commercial Distribution

  • 00630414953519 ()
LAPZ

  • Buffered sample diluent IVD

Atellica™ IM HBsII - 00630414599274

HBsAgII (HBsII) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995604
In Commercial Distribution

  • 00630414599274 ()
10995604

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Atellica™ IM HBsII Confirmatory - 00630414599267

HBsAg Confirmatory (HBsII Conf) - Atellica IM - RGT - 98T
Siemens Healthcare Diagnostics Inc.
10995603
In Commercial Distribution

  • 00630414599267 ()
10995603

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Atellica™ IM HBeAg - 00630414599236

Hepatitis Be Antigen (HBeAg) - Atellica IM - RGT - 50T
Siemens Healthcare Diagnostics Inc.
10995600
In Commercial Distribution

  • 00630414599236 ()
10995600

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay

Atellica™ IM HBcT - 00630414599205

HBC Total Ab (HBcT) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995597
In Commercial Distribution

  • 00630414599205 ()
10995597

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

Atellica™ IM aHBcM - 00630414597799

HBc IgM (aHBcM) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995449
In Commercial Distribution

  • 00630414597799 ()
10995449

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

ADVIA Centaur® aHBs2 - 00630414591407

Anti-HBs2 (aHBs2) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10698706
In Commercial Distribution

  • 00630414591407 ()
10698706

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® HBeAg - 00630414591315

Hepatitis B e Antigen (HBeAg) Assay Kit (1-pack) 50T
Siemens Healthcare Diagnostics Inc.
10698639
In Commercial Distribution

  • 00630414591315 ()
10698639

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
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