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Vaccines, Blood & Biologics
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 Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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