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-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Roche Diagnostics 9115 Hague Road Po Box 50416 Indianapolis, IN 46250 |
PMA Number | P190034 |
Supplement Number | S002 |
Date Received | 12/09/2021 |
Decision Date | 06/13/2023 |
Product Code |
LOM |
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 the migration of Elecsys Anti-HBs II assay on the cobas e 602 immunoanalyzer. |
|
|