cobas HBV/HCV/HIV-1 Control Kit for use on the cobas 4800 System - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, co

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

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PAR PAR (PAR)
22-11-2017

MAH:

Roche Diagnostics Australia Pty Limited

class:

Class 4

manufactured_by:

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

therapeutic_area:

48218 - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control

therapeutic_indication:

cobas HBV/HCV/HIV-1 Control Kit contains a Low Positive control, High Positive control and Negative control and is to be used as a batch control for the cobas HBV, cobas HCV, and cobas HIV-1 tests for use on the cobas 4800 System (nucleic acid technique). cobas HBV/HCV/HIV-1 Control Kit is used for the quality control of the cobas HBV, cobas HCV, and cobas HIV-1 tests for use on the cobas 4800 System.

authorization_status:

A

authorization_date:

2017-09-18