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Why would it be important to have this kit listed here? Can

Why would it be important to have this kit listed here? Can

Phlebotomy Essentials
Phlebotomy Essentials
6th Edition
ISBN:9781451194524
Author:Ruth McCall, Cathee M. Tankersley MT(ASCP)
Publisher:Ruth McCall, Cathee M. Tankersley MT(ASCP)
Chapter1: Phlebotomy: Past And Present And The Healthcare Setting
Section: Chapter Questions
Problem 1SRQ
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Manufacturers of self-contained test kits apply for and receive Food and Drug Administration (FDA) approval for their particular test to be on the Clinical Laboratory Improvement Amendment (CLIA) waived list. To find out if your particular brand of self-contained test kit is on the CLIA waived list, access an up-to-date listing at the FDA website(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/analyteswaived.cfm (Links to an external site.)) and use the key search term “Currently Waived Analytes” (be forewarned, though, that the list is very long) (Cited from Chap. 37). Research the link to the FDA to find your kit name on the list. Discuss the following questions: Why would it be important to have this kit listed here? Can a POL use kits that are not listed?
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