Vaccines, Blood & Biologics

COBAS TaqScreen MPX Test

Proper Name: Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA Assay
Tradename: COBAS TaqScreen MPX Test
Manufacturer: Roche Molecular Systems, Inc, License No. 1636

In the February 26, 2009 Corrected Approval Letter. Correction is made to (1) reflect that specimens from "other living donors" are not included in those specimens that can be tested in pools of up to six (change in original second paragraph, line 2), (2) clarify the claim for detection of HIV-1 Group O RNA and HIV-2 RNA (change in original second paragraph line 7), and (3) clarify that the test may be used to screen donations of Source Plasma under certain conditions (change in original third paragraph, line 1).

Supporting Documents

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 01/13/2015
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