PMA P010033S052
- Device
- QuantiFERON®-TB Gold Test and QuantiFERON®-TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S052
- Product code
- NCD
- Decision date
- 2026-01-23
- Classification
- Microbiology
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- an internal site to internal site transfer of a manufacturing process
Current openFDA PMA Record#
- Device
- QuantiFERON®-TB Gold Test and QuantiFERON®-TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S052
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2026-01-23
- Decision code
- OK30
- Date received
- 2025-12-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an internal site to internal site transfer of a manufacturing process