|
Device | LIAISON® XL MUREX HBsAg Qual Assay |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | DiaSorin Inc 1951 Northwestern Avenue Stillwater, MN 55082 |
PMA Number | P190017 |
Supplement Number | S012 |
Date Received | 05/10/2023 |
Decision Date | 06/07/2023 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approved for correction of typographical errors in the package insert of the LIAISON XL MUREX HBsAg Qual Assay. |