Alinity s Anti-HBc
STN: 125681
Proper Name: Hepatitis B Virus Core Antigen (E coli, Recombinant)
Tradename: Alinity s Anti-HBc
Manufacturer: Abbott GmbH & Co. KG
Indication:
- The Alinity s Anti-HBc assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma specimens on the Alinity s System.
- The Alinity s Anti-HBc assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HBc. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing serum specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens.
Product Information
Supporting Documents
- August 2, 2019 - Approval Letter Alinity s Anti-HBc
- July 18, 2019 Summary Basis for Regulatory Action - Alinity s Anti-HBc