Elecsys Anti-HCV II

STN:125803
Proper Name: Elecsys Anti-HCV II
Tradename: Elecsys Anti-HCV II
Manufacturer: Roche Diagnostics

Indication:

Indicated for Elecsys Anti-HCV II is an in vitro immunoassay for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma. Elecsys Anti-HCV 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. 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 the cobas e 801 analytical unit

Production Information

Package Insert - Elecsys Anti-HCV II

Package Insert - PreciControl Anti-HCV

Package Insert - PreciControl Release Anti-HCV

Supporting Documents

February 28, 2024 Approval Letter - Elecsys Anti-HCV II

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Elecsys Anti-HCV II

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