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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-HBs Controls
Abbott Ireland Diagnostics
07P8810
In Commercial Distribution

  • 00380740151300 ()
07P8810

  • Hepatitis B virus surface total antibody IVD, control
Alinity i Anti-HBs Reagent Kit 1200 Tests
Abbott Ireland Diagnostics
07P8856
In Commercial Distribution

  • 00380740149611 ()
07P8856

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Alinity i Anti-HBs Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P8851
In Commercial Distribution

  • 00380740149604 ()
07P8851

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Alinity i Anti-HBs Specimen Diluent
Abbott Ireland Diagnostics
07P8841
In Commercial Distribution

  • 00380740149598 ()
07P8841

  • Buffered sample diluent IVD
Alinity i Anti-HBs Calibrators
Abbott Ireland Diagnostics
07P8801
In Commercial Distribution

  • 00380740149574 ()
07P8801

  • Hepatitis B virus surface total antibody IVD, calibrator
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
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