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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme immunoassay, cortisol, salivary
Regulation Description Cortisol (hydrocortisone and hydroxycorticosterone) test system.
Definition The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease. This kit is not intended for use with serum or plasma samples. The device's intended use differs from the description in the classification regulation in that it is for use with saliva samples.
Product CodeNHG
Regulation Number 862.1205
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Incorrect or inadequate test results 4
High test results 2
Low test results 1
Total Device Problems 7

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 1 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Corp. II Jun-28-2007

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