Device |
system, nucleic acid amplification, mycobacterium tuberculosis complex |
Definition |
intended to detect Mycobacterium tuberculosis complex nucleic acids extracted from human respiratory specimens. These devices are non-multiplexed and intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings. |
Product Code | MWA |
Regulation Number |
866.3372
|
Device Class |
2
|
Premarket Approvals (PMA) |
2009 |
2010 |
2011 |
2012 |
2013 |
2014 |
2015 |
2016 |
2017 |
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2020 |
2021 |
2022 |
2023 |
2024 |
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1
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