|
Device | ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P090008 |
Supplement Number | S005 |
Date Received | 08/29/2011 |
Decision Date | 11/17/2011 |
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 |
Approval Order Statement APPROVAL FOR CHANGES TO THE MANUFACTURING PROCEDURE FOR THE BEAD COATING PROCESS OF THE INTERMEDIATE STORAGE FORM OF ELECYS COATED MICROPARTICLES. |