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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
Immunoassay for the in vitro 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. This test 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.

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 

Supporting Documents

 
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