|
Device | ELECSYS ANTI-HBC ON ELECSYS 2010 |
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 | P100032 |
Supplement Number | S005 |
Date Received | 01/31/2012 |
Decision Date | 12/20/2012 |
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 A TRANSFER OF A PORTION OF THE MANUFACTURING OPERATIONS FOR THE BULK SOLUTIONS OF REAGENTS R1 AND R2, AS WELL AS BULK SOLUTIONS OF PRETREATMENT REAGENTS TO NEWLY CONSTRUCTED MANUFACTURING SPACE. |