PMA P010033S043
- Device
- TB Gold and QuantiFERON - TB Gold Plus
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S043
- Product code
- NCD
- Decision date
- 2019-03-15
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Modification of in process manufacturing processes and lyophilization of a critical component.
Current openFDA PMA Record#
- Device
- TB Gold and QuantiFERON - TB Gold Plus
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S043
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2019-03-15
- Decision code
- OK30
- Date received
- 2019-02-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of in process manufacturing processes and lyophilization of a critical component.