PMA P080027S011

Device: ORAQUICK HCV RAPID ANTIBODY TEST
Applicant: OraSure Technologies, Inc.
PMA number: P080027
Supplement: S011
Product code: MZO
Decision date: 2013-05-28
Classification: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Approval order statement: APPROVAL OF THE ADDITION OF A VISUAL INSPECTION STEP IN THE ORAQUICK® HCV RAPID ANTIBODY TEST ASSAY CARD MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device: ORAQUICK HCV RAPID ANTIBODY TEST
Applicant: OraSure Technologies, Inc.
PMA number: P080027
Supplement: S011
Product code: MZO
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Decision date: 2013-05-28
Decision code: APPR
Date received: 2013-04-29
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL OF THE ADDITION OF A VISUAL INSPECTION STEP IN THE ORAQUICK® HCV RAPID ANTIBODY TEST ASSAY CARD MANUFACTURING PROCESS.