PMA P010033S050
- Device
- QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S050
- Product code
- NCD
- Decision date
- 2024-02-09
- Classification
- Microbiology
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- to add an alternative supplier of a critical component
Current openFDA PMA Record#
- Device
- QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S050
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2024-02-09
- Decision code
- OK30
- Date received
- 2024-01-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add an alternative supplier of a critical component