|
Device | ORAQUICK HCV RAPID ANTIBODY TEST |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | ORASURE TECHNOLOGIES INC. 220 East First Street Bethlehem, PA 18015 |
PMA Number | P080027 |
Supplement Number | S018 |
Date Received | 09/03/2014 |
Decision Date | 10/02/2014 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |