LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX HBsAg Confirmatory Test
FDA premarket approval P190017/S009 · decided 2023-04-13
Approval details
- PMA number
- P190017
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX HBsAg Confirmatory Test
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2022-10-18
- Decision date
- 2023-04-13
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Approval for removal of repeat testing for samples greater than or equal to 140 s/co by the LIAISON XL MUREX HBsAg Qual assay and removal of testing these samples with LIAISON XL MUREX HBsAg Confirmatory Test.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (K260770) | DiaSorin, Inc. | 2026-06-04 |
| LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (DEN250032) | DiaSorin, Inc. | 2025-12-23 |
| LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (K231214) | DiaSorin, Inc. | 2023-10-27 |
| LIAISON Anti-HAV; LIAISON XS (K223403) | DiaSorin, Inc. | 2022-12-09 |
| LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (K213858) | DiaSorin, Inc. | 2022-07-26 |
| LIAISON MeMed BV, LIAISON MeMed BV Control Set (K213936) | DiaSorin, Inc. | 2022-07-14 |
| LIAISON Ferritin (K193650) | DiaSorin, Inc. | 2021-09-14 |
| LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (K202573) | DiaSorin, Inc. | 2021-02-18 |