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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Chembio HIV 1/2 STAT-PAK Assay

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

  • 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
(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