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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 CORE-M Controls
Abbott GmbH
6L23-10
In Commercial Distribution

  • 00380740011147 ()
06L2310

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
ARCHITECT CORE-M Calibrators
Abbott GmbH
6L23-01
In Commercial Distribution

  • 00380740011130 ()
06L2301

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, calibrator
ARCHITECT CORE Reagent Kit
Abbott GmbH
6L22-25
In Commercial Distribution

  • 00380740011123 ()
06L2225

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
ARCHITECT CORE Controls
Abbott GmbH
6L22-10
In Commercial Distribution

  • 00380740011116 ()
06L2210

  • Hepatitis B virus core total antibody IVD, control
ARCHITECT CORE Calibrator
Abbott GmbH
6L22-01
In Commercial Distribution

  • 00380740011109 ()
06L2201

  • Hepatitis B virus core total antibody IVD, calibrator
ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent
Abbott Ireland Diagnostics
4P54-40
In Commercial Distribution

  • 00380740007805 ()
04P5440

  • Buffered sample diluent IVD
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
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