PMA P180047S001
- Device
- LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus
- Applicant
- DiaSorin, Inc.
- Product code
- NCD
- Decision date
- 2020-10-26
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Approval for change in supplier of reagent components.
Current openFDA PMA Record#
- Device
- LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus
- Applicant
- DiaSorin, Inc.
- PMA number
- P180047
- Supplement
- S001
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2020-10-26
- Decision code
- APPR
- Date received
- 2020-01-31
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for change in supplier of reagent components.