PMA P010033S045
- Device
- Quantiferon - TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S045
- Product code
- NCD
- Decision date
- 2019-04-29
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- Approval for changes to the stability/handling of whole blood specimens collected in lithium heparin (LiHep) blood collection tubes held at 2-8C, prior to transfer to the Quantiferon-TB Gold Plus blood collection tubes.
Current openFDA PMA Record#
- Device
- Quantiferon - TB Gold Plus Test
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S045
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2019-04-29
- Decision code
- APPR
- Date received
- 2019-04-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the stability/handling of whole blood specimens collected in lithium heparin (LiHep) blood collection tubes held at 2-8C, prior to transfer to the Quantiferon-TB Gold Plus blood collection tubes.