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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 i Anti-HBc Reagent Kit 1200 Tests
Abbott GmbH
07P8431
In Commercial Distribution

  • 00380740136666 ()
07P8431

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Alinity i Anti-HBc Reagent Kit 200 Tests
Abbott GmbH
07P8421
In Commercial Distribution

  • 00380740136659 ()
07P8421

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Alinity i Anti-HBc Controls
Abbott GmbH
07P8410
In Commercial Distribution

  • 00380740136642 ()
07P8410

  • Hepatitis B virus core total antibody IVD, control
Alinity i Anti-HBc Calibrator
Abbott GmbH
07P8401
In Commercial Distribution

  • 00380740136635 ()
07P8401

  • Hepatitis B virus core total antibody IVD, calibrator
Alinity i HBsAg Qualitative II Reagent Kit 1200 Tests
Abbott Ireland Diagnostics
08P1031
In Commercial Distribution

  • 00380740136598 ()
08P1031

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Alinity i HBsAg Qualitative II Reagent Kit 200 Tests
Abbott Ireland Diagnostics
08P1021
In Commercial Distribution

  • 00380740136581 ()
08P1021

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Alinity i HBsAg Qualitative II Confirmatory Reagent Kit 200 Tests
Abbott Ireland Diagnostics
08P1121
In Commercial Distribution

  • 00380740130459 ()
08P1121

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Alinity i Anti-HBc IgM Reagent Kit 200 Tests
Abbott GmbH
07P8621
In Commercial Distribution

  • 00380740130282 ()
07P8621

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
ARCHITECT AUSAB Specimen Diluent
Abbott Ireland Diagnostics
1L82-40
In Commercial Distribution

  • 00380740115388 ()
01L8240

  • Buffered sample diluent IVD
ARCHITECT AUSAB Reagent
Abbott Ireland Diagnostics
1L82-37
In Commercial Distribution

  • 00380740115371 ()
01L8237

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