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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resources for You

Chembio HIV 1/2 STAT-PAK Assay

Proper Name: Chembio HIV 1/2 STAT-PAK Assay
Tradename:
HIV 1/2 STAT-PAK Assay
Manufacturer: Chembio Diagnostic Systems, Inc.
Indication:

  • For the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-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