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

  • 00380740007799 ()
04P5425

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
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 HBsAg Qualitative Reagent Kit
Abbott Ireland Diagnostics
4P53-25
In Commercial Distribution

  • 00380740007775 ()
04P5325

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
ARCHITECT HBsAg Qualitative Controls
Abbott Ireland Diagnostics
4P53-10
In Commercial Distribution

  • 00380740007768 ()
04P5310

  • Hepatitis B virus surface antigen IVD, control
ARCHITECT HBsAg Qualitative Calibrators
Abbott Ireland Diagnostics
4P53-01
In Commercial Distribution

  • 00380740007751 ()
04P5301

  • Hepatitis B virus surface antigen IVD, calibrator
ARCHITECT AUSAB Reagent Kit
Abbott Ireland Diagnostics
1L82-35
In Commercial Distribution

  • 00380740001520 ()
01L8235

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
ARCHITECT AUSAB Reagent Kit
Abbott Ireland Diagnostics
1L82-25
In Commercial Distribution

  • 00380740001513 ()
01L8225

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
ARCHITECT AUSAB Controls
Abbott Ireland Diagnostics
1L82-12
In Commercial Distribution

  • 00380740001506 ()
01L8212

  • Hepatitis B virus surface total antibody IVD, control
ARCHITECT AUSAB Calibrators
Abbott Ireland Diagnostics
1L82-02
In Commercial Distribution

  • 00380740001490 ()
01L8202

  • Hepatitis B virus surface total antibody IVD, calibrator
Alinity i AFP Reagent Kit 1200 Tests
Abbott Ireland Diagnostics
07P9030
In Commercial Distribution

  • 00380740130824 ()
07P9030

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