PMA P010033S020
- Device
- QUANTIFERON -TB GOLD
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S020
- Product code
- NCD
- Decision date
- 2012-11-15
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- APPROVAL FOR A CHANGE IN THE FORMULATION OF THE WASH BUFFER 20X CONCENTRATE.
Current openFDA PMA Record#
- Device
- QUANTIFERON -TB GOLD
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S020
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2012-11-15
- Decision code
- APPR
- Date received
- 2012-04-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE FORMULATION OF THE WASH BUFFER 20X CONCENTRATE.