PMA P010033S005
- Device
- QUANTIFERON-TB KIT
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S005
- Product code
- NCD
- Decision date
- 2003-05-12
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- CHANGE THE SUPPLIER FOR PHYTOHAEMAGGLU-TININ (PHA-P), WHICH IS USED TO FORMULATE THE MITOGEN COMPONENT IN THE QUANTIFERON-TB KIT.
Current openFDA PMA Record#
- Device
- QUANTIFERON-TB KIT
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S005
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2003-05-12
- Decision code
- OK30
- Date received
- 2003-04-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE THE SUPPLIER FOR PHYTOHAEMAGGLU-TININ (PHA-P), WHICH IS USED TO FORMULATE THE MITOGEN COMPONENT IN THE QUANTIFERON-TB KIT.