LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
FDA premarket approval P180048 · decided 2020-08-29
Approval details
- PMA number
- P180048
- Trade name
- LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2018-12-14
- Decision date
- 2020-08-29
- Days to decision
- 624 days
- Decision code
- APRL
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Approval for the LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg. The LIAISON® XL MUREX HBeAg assay is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative detection of hepatitis B virus (HBV) e antigen (HBeAg) in human adult and pediatric (2-21 years) 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 u
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510(k) clearances by this applicant
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|---|---|---|
| LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (K260770) | DiaSorin, Inc. | 2026-06-04 |
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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 |