|
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 | S005 |
Date Received | 03/16/2011 |
Decision Date | 07/27/2011 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE OPTION TO AUTOMATE THE MANUFACTURING PROCESS FOR ASSEMBLY OF THE ORAQUICK® HCV RAPID ANTIBODY TEST. |