PMA P010033S007
- Device
- QUANTIFERON - TB
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S007
- Product code
- NCD
- Decision date
- 2004-02-10
- Classification
- Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Approval order statement
- CHANGE TO THE MANUFACTURING PROCESS OF THE QUANTIFERON-TB TO ALLOW THE USE OF K-BLUE MAX SUBSTRATE AS AN ALTERNATIVE SUBSTRATE REAGENT TO INCREASE THE SHELF LIFE OF THE KIT TO 3 YEARS.
Current openFDA PMA Record#
- Device
- QUANTIFERON - TB
- Applicant
- Qiagen
- PMA number
- P010033
- Supplement
- S007
- Product code
- NCD
- Generic name
- TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
- Decision date
- 2004-02-10
- Decision code
- OK30
- Date received
- 2004-01-14
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO THE MANUFACTURING PROCESS OF THE QUANTIFERON-TB TO ALLOW THE USE OF K-BLUE MAX SUBSTRATE AS AN ALTERNATIVE SUBSTRATE REAGENT TO INCREASE THE SHELF LIFE OF THE KIT TO 3 YEARS.