PMA P010033S031
- Device
- QUANTTFERON-TB GOLD Plus
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S031
- Product code
- NCD
- Decision date
- 2017-06-07
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Approval for a design change to the device TB Antigen blood collection tubes.
Current openFDA PMA Record#
- Device
- QUANTTFERON-TB GOLD Plus
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S031
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2017-06-07
- Decision code
- APPR
- Date received
- 2016-12-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the device TB Antigen blood collection tubes.