PMA P010033S032
- Device
- QuantiFERON-TB GOLD Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S032
- Product code
- NCD
- Decision date
- 2017-03-07
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Add an alternate critical raw material supplier and an additional vendor for testing of kit components.
Current openFDA PMA Record#
- Device
- QuantiFERON-TB GOLD Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S032
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2017-03-07
- Decision code
- OK30
- Date received
- 2017-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate critical raw material supplier and an additional vendor for testing of kit components.