|
Device | QuantiFeron TB Gold and QuantiFeron TB Gold Plus |
Generic Name | TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS |
Applicant | QIAGEN 19300 Germantown Road Germantown, MD 20874 |
PMA Number | P010033 |
Supplement Number | S037 |
Date Received | 01/11/2018 |
Decision Date | 08/24/2018 |
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 for a change to the testing process and specification for reagent components. |