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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma
Definition A quantitative measurement of soluble mesothelin related peptides (smrp) in human serum. Measurement of smrp may aid in the monitoring of mesothelioma patients diagnosed with epithelioid or biphasic mesothelioma. Values must be interpreted in conjunction with all other available clinical laboratory data.
Product CodeOAW
Device Class Humanitarian Device Exemption

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Fujirebio Diagnostics, Inc. III Mar-08-2011

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