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 | LIAISON® XL MUREX HBsAg Confirmatory |
Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
Applicant | DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS010 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-11-10 |
Decision Date | 2022-12-08 |
PMA | P190017 |
Supplement | S010 |
Product Code | LOM |
Advisory Committee | Microbiology |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | DiaSorin Inc 1951 Northwestern Avenue stillwater, MN 55082 PMA NumberP190017 Supplement NumberS010 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement elimination Of A Manufacturing Step For Kit Component |
Supplement Number | Date | Supplement Type |
---|---|---|
P190017 | Original Filing | |
S010 | 2022-11-10 | 30-day Notice |
S009 | ||
S008 | 2022-09-21 | Real-time Process |
S007 | ||
S006 | 2022-04-05 | Real-time Process |
S005 | 2022-04-05 | 30-day Notice |
S004 | 2022-02-04 | Real-time Process |
S003 | 2021-11-19 | Real-time Process |
S002 | 2021-05-27 | Real-time Process |
S001 |