Premarket Approval Information - Devices
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)
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