PMA P010033S041
- Device
- QuantiFERON-TB Gold Test / QuantiFERON TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S041
- Product code
- NCD
- Decision date
- 2018-10-30
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Approval for change in critical raw material of kit component.
Current openFDA PMA Record#
- Device
- QuantiFERON-TB Gold Test / QuantiFERON TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S041
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2018-10-30
- Decision code
- APPR
- Date received
- 2018-09-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for change in critical raw material of kit component.