|
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 | S016 |
Date Received | 03/04/2014 |
Decision Date | 07/11/2014 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE TRANSMITTER THAT COMBINES THECOMPONENTS FROM TWO PRINTED CIRCUIT BOARD ASSEMBLIES (PCBAS) INTO A SINGLE BOARD TRANSMITTER (SBT) WITH ONE PRINTED CIRCUIT BOARD (PCB). |