LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab
FDA premarket approval P190011 · decided 2019-10-18
Approval details
- PMA number
- P190011
- Trade name
- LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- DiaSorin, Inc.
- Date received
- 2019-04-22
- Decision date
- 2019-10-18
- Days to decision
- 179 days
- Decision code
- APRL
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Approval for the LIAISON XL MUREX HCV Ab. The LIAISON XL MUREX HCV Ab is an in vitro chemiluminescent immunoassay for the qualitative determination of specific antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric serum and plasma (lithium and sodium heparin, sodium citrate and potassium EDTA) samples including separator tubes, on the LIAISON XL Analyzer. It is intended to be used as an aid in the diagnosis of HCV infection. The assay may also be used as an aid in the diagnosis
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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 |