LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software
FDA premarket approval P180047/S034 · decided 2025-04-10
Approval details
- PMA number
- P180047
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2025-03-11
- Decision date
- 2025-04-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- to transfer to an alternate facility
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