Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | ELECSYS ANTI-HBC 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 | P100032 |
Supplement Number | S001 |
Date Received | 07/01/2011 |
Decision Date | 07/22/2011 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE WITHIN THE MANUFACTURING SITE TO INCREASE PRODUCTION CAPACITY FOR A COMPONENT OF THE STREPTAVIDIN- COATED MICROPARTICLES USED IN BOTH OF THESE ASSAYS. |
|
|