- Device
- LIAISON QuantiFERON-TB Gold Plus and LIAISON Control QuantiFERON-TB Gold Plus
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S008
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2021-09-17
- Decision code
- APPR
- Date received
- 2021-02-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for site change, to include manufacturing facility of DiaSorin Inc. located in Stillwater, Minnesota.