Premarket Approval Information - Devices
Applicant: Chembio Diagnostic Systems, Inc
Product: SURE CHECK HIV 1/2 ASSAY
PMA number: BP050009 / 0
Indication for Use: 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