|
Device | ORAQUICK RAPID HCV ANTIBODY |
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 | S003 |
Date Received | 02/23/2011 |
Decision Date | 10/20/2011 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR HOLD TIME EXTENSIONS FOR RAW MATERIAL, COMPONENTS AND IN-PROCESS MATERIAL FOR THE MANUFACTURING OF THE DEVICE. |