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Enzyme Immunoassay, Cortisol, Salivary

FDA product code NHG · 6 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1205
Review panel
CH
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2001-12-17 – 2012-05-08

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.

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