PMA P010033S016
- Device
- QUANTIFERON-TB GOLD IN-TUBE
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S016
- Product code
- NCD
- Decision date
- 2010-12-17
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- APPROVAL TO RELOCATE THE PEPTIDE FORMULATION FOR THE BLOOD COLLECTION TUBES FROM AUSTRALIA TO THE USA FACILITY IN CALIFORNIA.
Current openFDA PMA Record#
- Device
- QUANTIFERON-TB GOLD IN-TUBE
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S016
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2010-12-17
- Decision code
- APPR
- Date received
- 2010-05-20
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO RELOCATE THE PEPTIDE FORMULATION FOR THE BLOOD COLLECTION TUBES FROM AUSTRALIA TO THE USA FACILITY IN CALIFORNIA.