PMA P010033S037
- Device
- QuantiFeron TB Gold and QuantiFeron TB Gold Plus
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S037
- Product code
- NCD
- Decision date
- 2018-08-24
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Approval for a change to the testing process and specification for reagent components.
Current openFDA PMA Record#
- Device
- QuantiFeron TB Gold and QuantiFeron TB Gold Plus
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S037
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2018-08-24
- Decision code
- APPR
- Date received
- 2018-01-11
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the testing process and specification for reagent components.