PMA P010033S025
- Device
- QUANTIFERON- TB GOLD TEST
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S025
- Product code
- NCD
- Decision date
- 2014-12-04
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT QIAGEN IN GERMANTOWN, MARYLAND.
Current openFDA PMA Record#
- Device
- QUANTIFERON- TB GOLD TEST
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S025
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2014-12-04
- Decision code
- APPR
- Date received
- 2014-10-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT QIAGEN IN GERMANTOWN, MARYLAND.