PMA P010033S013
- Device
- QUANTIFERON - TB GOLD-IN-TUBE
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S013
- Product code
- NCD
- Decision date
- 2008-10-31
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- APPROVAL FOR THE ADDITION OF QUANTIFERON BLOOD COLLECTION TUBES SUITABLE FOR USE AT ALTITUDES ABOVE 6,500 FEET.
Current openFDA PMA Record#
- Device
- QUANTIFERON - TB GOLD-IN-TUBE
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S013
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2008-10-31
- Decision code
- APPR
- Date received
- 2008-06-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF QUANTIFERON BLOOD COLLECTION TUBES SUITABLE FOR USE AT ALTITUDES ABOVE 6,500 FEET.