|
Device | ELECSYS ANTI-HBS IMMUNOASSAY |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P010054 |
Supplement Number | S016 |
Date Received | 08/29/2011 |
Decision Date | 11/17/2011 |
Product Code |
LOM |
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. |