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 Plus Test |
Generic Name | TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS |
Applicant | QIAGEN 19300 Germantown Road Germantown, MD 20874 |
PMA Number | P010033 |
Supplement Number | S045 |
Date Received | 04/15/2019 |
Decision Date | 04/29/2019 |
Product Code |
NCD |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the stability/handling of whole blood specimens collected in lithium heparin (LiHep) blood collection tubes held at 2-8C, prior to transfer to the Quantiferon-TB Gold Plus blood collection tubes. |
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