PMA P010033S009
- Device
- QUANTIFERON -TB GOLD
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S009
- Product code
- NCD
- Decision date
- 2006-07-26
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- APPROVAL FOR A CONTRACT MANUFACTURING SITE LOCATED AT SCANTIBODIES LABORATORY, INC., SANTEE, CALIFORNIA.
Current openFDA PMA Record#
- Device
- QUANTIFERON -TB GOLD
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S009
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2006-07-26
- Decision code
- APPR
- Date received
- 2005-11-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CONTRACT MANUFACTURING SITE LOCATED AT SCANTIBODIES LABORATORY, INC., SANTEE, CALIFORNIA.