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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
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

MDR Year MDR Reports MDR Events
2019 1 1
2021 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 2 2
Low Test Results 2 2
Electrical Power Problem 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2 2
No Clinical Signs, Symptoms or Conditions 2 2

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