PMA P010033S002
- Device
- QUANTIFERON-TB
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S002
- Product code
- NCD
- Decision date
- 2002-12-17
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- CHANGE IN THE SUBSTRATE REAGENT USED IN THE KIT FROM A TWO-SOLUTION SUBSTRATE SYSTEM TO A ONE-SOLUTION SUBSTRATE SYSTEM.
Current openFDA PMA Record#
- Device
- QUANTIFERON-TB
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S002
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2002-12-17
- Decision code
- OK30
- Date received
- 2002-12-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE SUBSTRATE REAGENT USED IN THE KIT FROM A TWO-SOLUTION SUBSTRATE SYSTEM TO A ONE-SOLUTION SUBSTRATE SYSTEM.