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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
Product: Calypte HIV-1 Urine EIA
PMA number: BP000009
Indication for Use: HIV detection test used in professional laboratory settings as an aid in clinical diagnosis of HIV infection
Approval Date: 1/12/2001

Letter - (PDF)

Summary of Safety and Effectiveness - (PDF)

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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