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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeMWA
Regulation Number 866.3372
Device Class 2

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Roche Molecular Systems, Inc. II Jan-31-2013
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