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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 HBsAg Qualitative II Controls
Abbott Ireland Diagnostics
08P1012
In Commercial Distribution

  • 00380740146245 ()
08P1012

  • Hepatitis B virus surface antigen IVD, control
Alinity i HBsAg Qualitative II Calibrators
Abbott Ireland Diagnostics
08P1002
In Commercial Distribution

  • 00380740146238 ()
08P1002

  • Hepatitis B virus surface antigen IVD, calibrator
Alinity i HBsAg Qualitative II Confirmatory Manual Diluent 1 Tests
Abbott Ireland Diagnostics
08P1141
In Commercial Distribution

  • 00380740146214 ()
08P1141

  • Buffered sample diluent IVD
Alinity i Anti-HBc IgM Calibrators
Abbott GmbH
07P8602
In Commercial Distribution

  • 00380740146177 ()
07P8602

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, calibrator
Alinity i Anti-HBc IgM Controls
Abbott GmbH
07P8612
In Commercial Distribution

  • 00380740145187 ()
07P8612

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