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Vaccines, Blood & Biologics
Chembio HIV 1/2 STAT-PAK Assay
Applicant: Chembio Diagnostic Systems, Inc.
Product: Chembio HIV 1/2 STAT-PAK Assay
PMA number: BP050010/0
Indication for Use: 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
Summary of Safety & Effectiveness (PDF - 193 KB)
Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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