PMA P180047S015
- Device
- LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S015
- Product code
- NCD
- Decision date
- 2022-05-06
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Introduce an additional supplier for an assay accessory.
Current openFDA PMA Record#
- Device
- LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S015
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2022-05-06
- Decision code
- OK30
- Date received
- 2022-04-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce an additional supplier for an assay accessory.