LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers
FDA premarket approval P180039 · decided 2020-02-21
Approval details
- PMA number
- P180039
- Trade name
- LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- DiaSorin, Inc.
- Date received
- 2018-09-26
- Decision date
- 2020-02-21
- Days to decision
- 513 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Approval for the LIAISON XL MUREX Anti-HBs. The device is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative and quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) in human adult and pediatric (2 21 years) serum and plasma (lithium and sodium heparin and K2 EDTA) including separator tubes, on the LIAISON XL Analyzer. Assay results in conjunction with other hepatitis B virus (HBV) serological markers and clinical information may be used as an aid i
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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 |