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IVD Test Reagent/Kits, Home Assay, Whole Blood, Sampling

Definition : Reagents available as home test kits that permit the rapid collection of sample (i.e., specimen) of whole blood. These kits usually include the necessary devices and materials to obtain a whole blood sample (e.g., lancets, blood collection cards, alcohol towelettes, gauze pads, bandage); the kit usually includes a unique personal identification code and booklets with sampling instructions and information appropriate to the intended test to be performed. Whole blood sampling kits for home use permit patients to collect specimens in the privacy of their home; the samples are intended for anonymous analysis in a qualified laboratory for primary detection of microorganisms (e.g., HIV, hepatitis C virus), which are not considered possible or convenient for home assessment.

Entry Terms : "Whole Blood Sampling Home-Test Kits" , "HIV Sampling Home-Test Kits" , "Human Immunodeficiency Virus Sampling Home-Test Kits" , "Hepatitis Virus Sampling Home-Test Kits" , "Reagents, Home-Test Kits, Whole Blood, Sampling"

UMDC code : 24239

U.S.companies only
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