LIAISON® QuantiFERON® - TB Gold Plus, LIAISON® XL Control QuantiFERON-TB Gold Plus
FDA premarket approval P180047/S026 · decided 2024-07-12
Approval details
- PMA number
- P180047
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIAISON® QuantiFERON® - TB Gold Plus, LIAISON® XL Control QuantiFERON-TB Gold Plus
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- DiaSorin, Inc.
- Date received
- 2024-06-17
- Decision date
- 2024-07-12
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- to change the cleaning process for equipment used to manufacture critical assay components
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