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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 - 00380740157012

ARCHITECT HBsAg Next Qualitative Reagent Kit (500T)
Abbott Ireland Diagnostics
4P76-37
In Commercial Distribution

  • 00380740157012 ()
04P7637

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

ARCHITECT - 00380740156992

ARCHITECT HBsAg Next Qualitative Reagent Kit (100T)
Abbott Ireland Diagnostics
4P76-27
In Commercial Distribution

  • 00380740156992 ()
04P7627

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

Alinity - 00380740151300

Alinity i Anti-HBs Controls
Abbott Ireland Diagnostics
07P8810
In Commercial Distribution

  • 00380740151300 ()
07P8810

  • Hepatitis B virus surface total antibody IVD, control

Alinity - 00380740149611

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 - 00380740149604

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 - 00380740149598

Alinity i Anti-HBs Specimen Diluent
Abbott Ireland Diagnostics
07P8841
In Commercial Distribution

  • 00380740149598 ()
07P8841

  • Buffered sample diluent IVD

Alinity - 00380740149574

Alinity i Anti-HBs Calibrators
Abbott Ireland Diagnostics
07P8801
In Commercial Distribution

  • 00380740149574 ()
07P8801

  • Hepatitis B virus surface total antibody IVD, calibrator

Alinity - 00380740136659

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 - 00380740136598

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 - 00380740136581

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
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