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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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Atellica IM HBcT2 - 00630414637877

Atellica IM HBcT2 (REF) 500T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11643118
In Commercial Distribution

  • 00630414637877 ()
11643118

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

Atellica IM HBcT2 QC - 00630414604336

HBc Total 2 (HBcT2) Atellica IM - CLT 2 x 2 x 7.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200740
In Commercial Distribution

  • 00630414604336 ()
11200740

  • Hepatitis B virus core total antibody IVD, control

Atellica IM HBcT2 - 00630414604138

HBc Total 2 (HBcT2) Atellica IM - RGT 100T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200739
In Commercial Distribution

  • 00630414604138 ()
11200739

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

Alinity - 00380740160593

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 - 00380740160579

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

ARCHITECT - 00380740158187

ARCHITECT HBsAg Next Confirmatory Reagent Kit (100T)
Abbott Ireland Diagnostics
4P77-27
In Commercial Distribution

  • 00380740158187 ()
04P7727

  • 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
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