PMA P080027S018

Device: ORAQUICK HCV RAPID ANTIBODY TEST
Applicant: OraSure Technologies, Inc.
PMA number: P080027
Supplement: S018
Product code: MZO
Decision date: 2014-10-02
Classification: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Approval order statement: APPROVAL FOR THE ADDITION OF AN IN-PROCESS INSPECTION AS PART OF THE POUCHING PROCESS FOR THE ORAQUICK HCV RAPID ANTIBODY TEST.

Current openFDA PMA Record#

Device: ORAQUICK HCV RAPID ANTIBODY TEST
Applicant: OraSure Technologies, Inc.
PMA number: P080027
Supplement: S018
Product code: MZO
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Decision date: 2014-10-02
Decision code: APPR
Date received: 2014-09-03
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF AN IN-PROCESS INSPECTION AS PART OF THE POUCHING PROCESS FOR THE ORAQUICK HCV RAPID ANTIBODY TEST.