PreciControl Anti-HCV (cobas e 411/601/602) - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Διαθέσιμο από:

Roche Diagnostics Australia Pty Limited

Kατηγορία:

Class 4

Κατασκευάζεται από:

Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany

Θεραπευτική περιοχή:

41973 - Hepatitis C virus total antibody IVD, control

Θεραπευτικές ενδείξεις:

PreciControl Anti-HCV is a ready-for-use control serum based on human serum both in the negative and positive concentration range. The controls are used for monitoring the accuracy of the Elecsys Anti-HCV and Elecsys Anti-HCV II immunoassays. PreciControl Anti-HCV is used for quality control of the Anti-HCV and Anti-HCV II immunoassays on the Elecsys and cobas e immunoassay analyzers.

Καθεστώς αδειοδότησης:

A

Ημερομηνία της άδειας:

2013-09-13