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510(k) Data Aggregation
K Number
K102841Device Name
PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY
Manufacturer
PANTEX, DIV. BIO-ANALYSIS, INC.
Date Cleared
2012-05-08
(587 days)
Product Code
NHG
Regulation Number
862.1205Why did this record match?
Applicant Name (Manufacturer) :
PANTEX, DIV. BIO-ANALYSIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the in-vitro diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease. Measurements of cortisol in saliva are used in the diagnosis and treatment of disorders of the adrenal gland.
Device Description
The kit consists of a 96 well GARGG (Goat Anti-Rabbit Gamma Globulin) coated microplate (12x8 breakable strip wells), seven ready-to-use calibrators (range 0.1-30 ng/ml) of gravimetrically prepared cortisol from a commercial source (Steraloids) and compared and traced to NIST cortisol, low and high controls, anti-Cortisol (rabbit), 10X concentrated Cortisol (analog)-peroxidase, substrate solution, stop reaction solution and 10X concentrated wash solution.
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