PMA P010033S046
- Device
- QuantiFERON – TB Gold and QuantiFERON-TB Gold Plus
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S046
- Product code
- NCD
- Decision date
- 2019-12-06
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Addition of a new alternative supplier for a critical raw material.
Current openFDA PMA Record#
- Device
- QuantiFERON – TB Gold and QuantiFERON-TB Gold Plus
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S046
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2019-12-06
- Decision code
- OK30
- Date received
- 2019-11-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new alternative supplier for a critical raw material.