PMA P180047S046
- Device
- LIAISON® QuantiFERON®-TB Gold Plus II.
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S046
- Product code
- NCD
- Decision date
- 2026-09-24
- Classification
- Microbiology
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- a manufacturing scale-up
Current openFDA PMA Record#
- Device
- LIAISON® QuantiFERON®-TB Gold Plus II.
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S046
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2026-09-24
- Decision code
- OK30
- Date received
- 2026-09-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing scale-up