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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 HBsAg Next Qualitative Calibrators
Abbott Ireland Diagnostics
4P76-02
In Commercial Distribution

  • 00380740208486 ()
04P7602

  • Hepatitis B virus surface antigen IVD, calibrator
ARCHITECT HBsAg Next Confirmatory Manual Diluent
Abbott Ireland Diagnostics
4P77-42
In Commercial Distribution

  • 00380740208479 ()
04P7742

  • Buffered sample diluent IVD
ARCHITECT HBsAg Next Qualitative Controls
Abbott Ireland Diagnostics
4P76-12
In Commercial Distribution

  • 00380740208462 ()
04P7612

  • Hepatitis B virus surface antigen IVD, control
Alinity i Anti-HBs Reagent Kit (1200T)
Abbott Ireland Diagnostics
07P8857
In Commercial Distribution

  • 00380740173562 ()
07P8857

  • Hepatitis B virus surface total antibody IVD, reagent
Alinity i Anti-HBs Reagent Kit (200T)
Abbott Ireland Diagnostics
07P8852
In Commercial Distribution

  • 00380740173555 ()
07P8852

  • Hepatitis B virus surface total antibody IVD, reagent
Alinity i HBsAg Next Qualitative Reagent Kit (1200T)
Abbott Ireland Diagnostics
01R6431
In Commercial Distribution

  • 00380740160593 ()
01R6431

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Alinity i HBsAg Next Qualitative Reagent Kit (200T)
Abbott Ireland Diagnostics
01R6421
In Commercial Distribution

  • 00380740160579 ()
01R6421

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
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 Specimen Diluent
Abbott Ireland Diagnostics
07P8841
In Commercial Distribution

  • 00380740149598 ()
07P8841

  • Buffered sample diluent IVD
Alinity i HBsAg Qualitative II Confirmatory Manual Diluent 1 Tests
Abbott Ireland Diagnostics
08P1141
In Commercial Distribution

  • 00380740146214 ()
08P1141

  • Buffered sample diluent IVD
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