Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | QUANTIFERON-TB GOLD AND TB GOLD Test (reference lab pack) |
Generic Name | TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS |
Applicant | QIAGEN 19300 Germantown Road Germantown, MD 20874 |
PMA Number | P010033 |
Supplement Number | S029 |
Date Received | 07/21/2016 |
Decision Date | 08/19/2016 |
Product Code |
NCD |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of two alternate suppliers for a raw material used to produce a critical assay component. |
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