PMA P010033S042
- Device
- QuantiFERON - TB Gold Test, QuantiFERON - TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S042
- Product code
- NCD
- Decision date
- 2019-01-04
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Replace a raw material and scale-up the production of an associated bulk solution.
Current openFDA PMA Record#
- Device
- QuantiFERON - TB Gold Test, QuantiFERON - TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S042
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2019-01-04
- Decision code
- OK30
- Date received
- 2018-12-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace a raw material and scale-up the production of an associated bulk solution.