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-HBe, PreciControl Anti-HBe |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
PMA Number | P190005 |
Supplement Number | S002 |
Date Received | 09/30/2022 |
Decision Date | 05/16/2023 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for use of the Elecsys Anti-HBe with the cobas e 402 immunoassay analyzer. |
|
|