PMA P010033S010
- Device
- QUANTIFERON-TB GOLD
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S010
- Product code
- NCD
- Decision date
- 2006-03-10
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- APPROVAL FOR LABLEING CHANGE TO THE WORDING OF THE INTERPRETATION OF THE TEST TO REMOVE AMBIGUITY AND ENHANCE SAFE USE.
Current openFDA PMA Record#
- Device
- QUANTIFERON-TB GOLD
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S010
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2006-03-10
- Decision code
- APPR
- Date received
- 2006-02-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABLEING CHANGE TO THE WORDING OF THE INTERPRETATION OF THE TEST TO REMOVE AMBIGUITY AND ENHANCE SAFE USE.