Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm
STN: 125802/0
Proper Name: Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm
Tradename: Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm
Manufacturer: Roche Diagnostics
Indication:
Intended Use for Elecsys HBsAg II
Elecsys HBsAg II is an in vitro immunoassay intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma. Elecsys HBsAg II is intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma. 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 and in testing serum specimens to screen cadaveric donors when specimens are obtained after the donor’s heart has stopped beating. It is not intended for use on cord blood specimens.
Intended Use for Elecsys HBsAg II Auto Confirm
Immunoassay for the in vitro qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma samples repeatedly reactive when tested with the Elecsys HBsAg II assay. Elecsys HBsAg II Auto Confirm is intended to confirm HBsAg presence in individual human donors, including volunteer donors of whole blood, blood components and source plasma. This test is also intended to be used to confirm HBsAg presence in organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating.
The electrochemiluminescence immunoassay “ECLIA” is intended for use with cobas pro serology solution.
Production Information
- Package Insert - Elecsys HBsAg II
- Package Insert - Elecsys HBsAg II Auto Confirm
- Package Insert - PreciControl HBsAg Auto Confirm
- Package Insert - PreciControl HBsAg II
- Package Insert - PreciControl Release HBsAg II