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

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
22-11-2017

から入手可能:

Roche Diagnostics Australia Pty Limited

クラス:

Class 4

製:

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

治療領域:

41973 - Hepatitis C virus total antibody IVD, control

適応症:

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.

認証ステータス:

A

承認日:

2013-09-13

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