LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software
FDA premarket approval P180047 · decided 2019-11-26
Approval details
- PMA number
- P180047
- Trade name
- LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- DiaSorin, Inc.
- Date received
- 2018-12-10
- Decision date
- 2019-11-26
- Days to decision
- 351 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Approval for the LIAISON QuantiFERON-TB Gold Plus assay, the LIAISON Control QuantiERON-TB Gold Plus, and the LIAISON QuantiFERON Software.The LIAISON QuantiFERON-TB Gold Plus assay is an in vitro diagnostic test intended for the detection of interferon-y (IFN-y) in human lithium heparin plasma by chemiluminescence immunoassay (CLIA) using the LIAISON XL Analyzer. QIAGEN QuantiFERON-TB Gold Plus Blood Collection Tubes, containing a peptide cocktail simulating ESAT-6, and CFP-10 proteins, are use
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