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IVD Test Reagent/Kits, Home Assay

Definition : Reagents available as a set (kit) that permits the determination of one or more analytes of interest in a sample of body fluids, typically whole blood, urine, or feces. These kits are designed for rapid testing (typically a few minutes) that can be performed at home by the patient or other non-healthcare provider with minimum training. Many reagents available in kits for home use may be available without prescription. They permit patients to check and/or control the levels of substances (e.g., glucose) that characterize a specific illness, to follow the progress of medical treatments, or to identify particular conditions (e.g., pregnancy) .

Entry Terms : "Kits, Home Test" , "Test Kits, Home Use" , "Home-Test Kits" , "Reagents, Strip" , "Reagents, Home-Test Kit"

UMDC code : 19309

U.S.companies only
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