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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resources for You

COBAS AmpliScreen HCV Test

Proper Name: Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived)
Tradename: COBAS AmpliScreen HCV Test, version 2.0
Manufacturer: Roche Molecular Systems, Inc
Indication:

  • Detecting HCV RNA, in conjunction with licensed tests for detecting antibodies to HCV
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Supporting Documents

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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