Food and Drug Administration - December 30, 2004
Richard Klein

The Food and Drug Administration (FDA) has approved a marketing application (PMA) for the Multispot HIV-1/HIV-2 Rapid Test. This device is indicated 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.

The test is manufactured by Bio-Rad Laboratories, Redmond, WA.

Additional information about this approval is available on the FDA website:

www.fda.gov/cber/pmaltr/P040046L.htm - Letter - (Text)

Summary of Safety and Effectiveness - (PDF)

Label - (PDF)

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues Food and Drug Administration

041230
FD041207

SOURCE: Food and Drug Administration (FDA).

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