LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM
FDA premarket approval P180045 · decided 2020-08-29
Approval details
- PMA number
- P180045
- Trade name
- LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- DiaSorin, Inc.
- Date received
- 2018-12-06
- Decision date
- 2020-08-29
- Days to decision
- 632 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Approval for the LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM. The LIAISON® XL MUREX HBc IgM assay is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative detection of IgM antibodies to hepatitis B virus core antigen (HBc IgM) in human adult and pediatric (2 to 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 hepatitis B virus (HBV
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510(k) clearances by this applicant
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|---|---|---|
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