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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Chembio SURE CHECK HIV 1/2 Assay

Proper Name: Chembio SURE CHECK HIV 1/2 Assay
Tradename: SURE CHECK HIV 1/2 Assay
Manufacturer: Chembio Diagnostic Systems, Inc
Indication:

  • For the detection of antibodies to HIV 1 & 2 in fingerstick whole blood, venous whole blood, and serum or plasma specimens

Approval Date: 5/25/2006

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002