Premarket Approval Information - Devices

Applicant: Chembio Diagnostic Systems, Inc.
Product: HIV 1/2 STAT-PAKT 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


Letter

Label (PDF)
Label (Text)

Summary of Safety & Effectiveness (PDF)
Summary of Safety & Effectiveness (Text)

 
Updated: June 28, 2006