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Premarket Approval Information - Devices

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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

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Letter - (Text)

Summary of Safety and Effectiveness - (PDF)

Label - (PDF)

Subject Information Notice - (PDF)

 

Updated December 28, 2004
 
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