PMA P010033S053
- Device
- QuantiFERON-TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S053
- Product code
- NCD
- Decision date
- 2026-10-14
- Classification
- Microbiology
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- changes to the lyophilization process
Current openFDA PMA Record#
- Device
- QuantiFERON-TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S053
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2026-10-14
- Decision code
- OK30
- Date received
- 2026-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the lyophilization process