|
Device | QUANTIFERON-TB GOLD IN-TUBE |
Generic Name | TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS |
Applicant | QIAGEN 19300 Germantown Road Germantown, MD 20874 |
PMA Number | P010033 |
Supplement Number | S016 |
Date Received | 05/20/2010 |
Decision Date | 12/17/2010 |
Product Code |
NCD |
Advisory Committee |
Microbiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO RELOCATE THE PEPTIDE FORMULATION FOR THE BLOOD COLLECTION TUBES FROM AUSTRALIA TO THE USA FACILITY IN CALIFORNIA. |