PMA P010033S040
- Device
- QuantiFERON TB Gold Test, QuantiFERON TB Gold Test (reference lab pack), QuantiFERON TB Gold Plus Test, QuantiFERON TB G
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S040
- Product code
- NCD
- Decision date
- 2018-10-04
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Change in sub-bulk component manufacturing.
Current openFDA PMA Record#
- Device
- QuantiFERON TB Gold Test, QuantiFERON TB Gold Test (reference lab pack), QuantiFERON TB Gold Plus Test, QuantiFERON TB G
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S040
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2018-10-04
- Decision code
- OK30
- Date received
- 2018-09-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in sub-bulk component manufacturing.