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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
(301) 827-1800
Consumer Affairs Branch (CBER)

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Food and Drug Administration

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Rockville, MD 20852-1448