Premarket Approval Information - Devices
Applicant: Bio-Rad Laboratories, Redmond, WA 98052
Product: Multispot HIV-1/HIV-2 Rapid Test
PMA number: BP040046/0
Indication for Use: For the detection and differentiation of circulating antibodies associated with HIV-1 and HIV-2 in human plasma and serum, as an aid in the diagnosis of infection with HIV-1 and/or HIV-2
Approval Date: 11/12/2004
Letter -
(Text)
Summary of Safety and Effectiveness -
(PDF)
Label -
(PDF)
Subject Information Notice -
(PDF)
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