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Vaccines, Blood & Biologics

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Multispot HIV-1/HIV-2 Rapid Test

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

Summary of Safety and Effectiveness (PDF - 65 KB)

Label (PDF - 221 KB)

Subject Information Notice (PDF - 211 KB)

    
 

Contact Us

  • (800) 835-4709
  • (301) 827-1800
  • Consumer Affairs Branch (CBER)

    Division of Communication and Consumer Affairs

    Office of Communication, Outreach and Development

    Food and Drug Administration

    1401 Rockville Pike

    Suite 200N/HFM-47

    Rockville, MD 20852-1448

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