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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 - 00380740009007

ARCHITECT Free PSA Calibrators
Abbott Ireland Diagnostics
6C07-01
In Commercial Distribution

  • 00380740009007 ()
06C0701

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

ARCHITECT - 00380740008994

ARCHITECT Total PSA Reagent Kit
Abbott Ireland Diagnostics
6C06-35
In Commercial Distribution

  • 00380740008994 ()
06C0635

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

ARCHITECT - 00380740008987

ARCHITECT Total PSA Reagent Kit
Abbott Ireland Diagnostics
6C06-27
In Commercial Distribution

  • 00380740008987 ()
06C0627

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

ARCHITECT - 00380740008970

ARCHITECT Total PSA Controls
Abbott Ireland Diagnostics
6C06-10
In Commercial Distribution

  • 00380740008970 ()
06C0610

  • Total prostate specific antigen (tPSA) IVD, control

ARCHITECT - 00380740008963

ARCHITECT Total PSA Calibrators
Abbott Ireland Diagnostics
6C06-01
In Commercial Distribution

  • 00380740008963 ()
06C0601

  • Total prostate specific antigen (tPSA) IVD, calibrator

ARCHITECT - 00380740007805

ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent
Abbott Ireland Diagnostics
4P54-40
In Commercial Distribution

  • 00380740007805 ()
04P5440

  • Buffered sample diluent IVD

ARCHITECT - 00380740007799

ARCHITECT HBsAg Qualitative Confirmatory Reagent Kit
Abbott Ireland Diagnostics
4P54-25
In Commercial Distribution

  • 00380740007799 ()
04P5425

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

ARCHITECT - 00380740007782

ARCHITECT HBsAg Qualitative Reagent Kit
Abbott Ireland Diagnostics
4P53-35
In Commercial Distribution

  • 00380740007782 ()
04P5335

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

ARCHITECT - 00380740007775

ARCHITECT HBsAg Qualitative Reagent Kit
Abbott Ireland Diagnostics
4P53-25
In Commercial Distribution

  • 00380740007775 ()
04P5325

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

ARCHITECT - 00380740007768

ARCHITECT HBsAg Qualitative Controls
Abbott Ireland Diagnostics
4P53-10
In Commercial Distribution

  • 00380740007768 ()
04P5310

  • Hepatitis B virus surface antigen IVD, control
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