|
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 | S011 |
Date Received | 04/29/2013 |
Decision Date | 05/28/2013 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL OF THE ADDITION OF A VISUAL INSPECTION STEP IN THE ORAQUICK® HCV RAPID ANTIBODY TEST ASSAY CARD MANUFACTURING PROCESS. |