Vaccines, Blood & Biologics

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

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Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 07/27/2009
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