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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Cambridge Biotech HIV-1 Urine Western Blot

Applicant: Calypte Biomedical Corp, Alameda, CA 94502
Product: Cambridge Biotech HIV-1 Urine Western Blot
PMA number: BP010009
Indication for Use: In vitro qualitative assay for detection and identification of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1)
Approval Date: 6/21/2001

Letter - (PDF)

Summary of Safety and Effectiveness - (PDF)


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