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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Calypte HIV-1 Urine EIA

Applicant: Calypte Biomedical Corp, Alameda, CA 94502
Calypte HIV-1 Urine EIA
PMA number:
Indication for Use:
HIV detection test used in professional laboratory settings as an aid in clinical diagnosis of HIV infection
Approval Date:

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