STN: 125804/0
Proper Name: Elecsys Anti-HBc II
Tradename: Elecsys Anti-HBc II
Manufacturer: Roche Diagnostics

Indication: 

Elecsys Anti-HBc II is an in vitro immunoassay for the qualitative detection of antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma. Elecsys Anti-HBc II is intended to screen individual human donors, including volunteer donors of whole blood and blood components. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens.

The electrochemiluminescence immunoassay “ECLIA” is intended for use with cobas pro serology solution-equipped with cobas e 801 analytical unit.

Production Information 

Package Insert - Elecsys Anti-HBc II

Package Insert - PreciControl Anti-HBc II

Package Insert - PreciControl Release Anti-HBc II

 

Supporting Documents

February 27, 2024 Approval Letter - Elecsys Anti-HBc II