LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc
FDA premarket approval P180038 · decided 2020-01-02
Approval details
- PMA number
- P180038
- Trade name
- LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- DiaSorin, Inc.
- Date received
- 2018-09-26
- Decision date
- 2020-01-02
- Days to decision
- 463 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Approval for the LIAISON XL MUREX Anti-HBc assay is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative detection of IgG and IgM (total) antibodies to hepatitis B core antigen (anti-HBc) in human adult and pediatric serum and plasma (lithium and sodium heparin, sodium citrate and K2 EDTA) including separator tubes, on the LIAISON XL Analyzer. Assay results in conjunction with other laboratory results and clinical information may be used as an aid in the diagnosis of hepatitis B v
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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 |
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| LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (K231214) | DiaSorin, Inc. | 2023-10-27 |
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| LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (K213858) | DiaSorin, Inc. | 2022-07-26 |
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| 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 |