PMA P010033S012
- Device
- QUANTIFERON TB GOLD
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S012
- Product code
- NCD
- Decision date
- 2007-11-28
- 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 CELESTIS LIMITED, VICTORIA, AUSTRALIA FOR THE BULK FORMULATION OF PEPTIDES.
Current openFDA PMA Record#
- Device
- QUANTIFERON TB GOLD
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S012
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2007-11-28
- Decision code
- APPR
- Date received
- 2007-03-16
- 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 CELESTIS LIMITED, VICTORIA, AUSTRALIA FOR THE BULK FORMULATION OF PEPTIDES.