Premarket Approval Information - Devices
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)
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