LIAISON QuantiFERON TB Gold Plus
FDA premarket approval P180047/S003 · decided 2020-07-23
Approval details
- PMA number
- P180047
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIAISON QuantiFERON TB Gold Plus
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- DiaSorin, Inc.
- Date received
- 2020-06-04
- Decision date
- 2020-07-23
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Approval of change in the LIAISON QuantiFERON-TB Gold Plus assay protocol reagent dispensation sequence.
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