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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 - 00380740163389

ARCHITECT HBsAg Next Qualitative Reagent Kit (2000T)
Abbott Ireland Diagnostics
4P76-32
In Commercial Distribution

  • 00380740163389 ()
04P7632

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

Alinity - 00380740161262

Alinity i HBsAg Next Confirmatory Reagent Kit (200T)
Abbott Ireland Diagnostics
01R6521
In Commercial Distribution

  • 00380740161262 ()
01R6521

  • 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

Alinity - 00380740158347

Alinity i Free PSA Reagent Kit 1000 Tests
Abbott Ireland Diagnostics
07P9331
In Commercial Distribution

  • 00380740158347 ()
07P9331

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

Alinity - 00380740158330

Alinity i Free PSA Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P9321
In Commercial Distribution

  • 00380740158330 ()
07P9321

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

Alinity - 00380740158323

Alinity i Total PSA Reagent Kit 1200 Tests
Abbott Ireland Diagnostics
07P9231
In Commercial Distribution

  • 00380740158323 ()
07P9231

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

Alinity - 00380740158316

Alinity i Total PSA Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P9221
In Commercial Distribution

  • 00380740158316 ()
07P9221

  • Total prostate specific antigen (tPSA) 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

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

Alinity - 00380740151300

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

  • 00380740151300 ()
07P8810

  • Hepatitis B virus surface total antibody IVD, control
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