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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 - 00380740130305

Alinity i Free PSA Calibrators
Abbott Ireland Diagnostics
07P9301
In Commercial Distribution

  • 00380740130305 ()
07P9301

  • Free (unbound) prostate specific antigen (fPSA) IVD, calibrator

Alinity - 00380740130282

Alinity i Anti-HBc IgM Reagent Kit 200 Tests
Abbott GmbH
07P8621
In Commercial Distribution

  • 00380740130282 ()
07P8621

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740112400

ARCHITECT AFP Reagent Kit
Abbott Ireland Diagnostics
3P36-35
In Commercial Distribution

  • 00380740112400 ()
03P3635

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

Alinity - 00380740173562

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 - 00380740173555

Alinity i Anti-HBs Reagent Kit (200T)
Abbott Ireland Diagnostics
07P8852
In Commercial Distribution

  • 00380740173555 ()
07P8852

  • Hepatitis B virus surface total antibody IVD, reagent

ARCHITECT - 00380740171759

ARCHITECT AUSAB Reagent Kit (500T)
Abbott Ireland Diagnostics
01L8238
In Commercial Distribution

  • 00380740171759 ()
01L8238

  • Hepatitis B virus surface total antibody IVD, reagent

ARCHITECT - 00380740171742

ARCHITECT AUSAB Reagent Kit (100T)
Abbott Ireland Diagnostics
01L8228
In Commercial Distribution

  • 00380740171742 ()
01L8228

  • Hepatitis B virus surface total antibody IVD, reagent

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

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 - 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
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