LIAISON® QuantiFERON TB-Gold Plus assay and Control
FDA premarket approval P180047/S016 · decided 2022-06-23
Approval details
- PMA number
- P180047
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIAISON® QuantiFERON TB-Gold Plus assay and Control
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Applicant
- DiaSorin, Inc.
- Date received
- 2022-04-05
- Decision date
- 2022-06-23
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- NCD
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Approval for the addition of the alternate supplier, Balda Medical GmbH (Bad Oeynhausen, Germany), to produce vial and frame plastics components of the Reagent Integral.
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