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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 - 00380740130459

Alinity i HBsAg Qualitative II Confirmatory Reagent Kit 200 Tests
Abbott Ireland Diagnostics
08P1121
In Commercial Distribution

  • 00380740130459 ()
08P1121

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

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 - 00380740115388

ARCHITECT AUSAB Specimen Diluent
Abbott Ireland Diagnostics
1L82-40
In Commercial Distribution

  • 00380740115388 ()
01L8240

  • Buffered sample diluent IVD

ARCHITECT - 00380740115371

ARCHITECT AUSAB Reagent
Abbott Ireland Diagnostics
1L82-37
In Commercial Distribution

  • 00380740115371 ()
01L8237

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740115364

ARCHITECT AUSAB Reagent
Abbott Ireland Diagnostics
1L82-27
In Commercial Distribution

  • 00380740115364 ()
01L8227

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740105433

ARCHITECT AUSAB Reagent
Abbott Ireland Diagnostics
1L82-36
In Commercial Distribution

  • 00380740105433 ()
01L8236

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740105426

ARCHITECT AUSAB Reagent
Abbott Ireland Diagnostics
1L82-26
In Commercial Distribution

  • 00380740105426 ()
01L8226

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

ARCHITECT - 00380740105419

ARCHITECT AUSAB Controls
Abbott Ireland Diagnostics
1L82-13
In Commercial Distribution

  • 00380740105419 ()
01L8213

  • Hepatitis B virus surface total antibody IVD, control

ARCHITECT - 00380740105402

ARCHITECT AUSAB Calibrators
Abbott Ireland Diagnostics
1L82-03
In Commercial Distribution

  • 00380740105402 ()
01L8203

  • Hepatitis B virus surface total antibody IVD, calibrator

ARCHITECT - 00380740011154

ARCHITECT CORE-M Reagent Kit
Abbott GmbH
6L23-25
In Commercial Distribution

  • 00380740011154 ()
06L2325

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