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CLIA WAIVED PRODUCTS |
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US DRUG TESTING - 168 DEER RD RICHMOND HILL, GA 31324 Toll Free: 1-866-525-8208 Email: usdtesting@comcast.net CALL OR EMAIL FOR PRICING & QUANTITY DISCOUNTS CLIA WAIVED PRODUCTS offered by USDT are products that have been approved for use by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) law that specified that laboratory requirements be based on the complexity of the test performed and established provisions for categorizing a test as waived. Tests may be waived from regulatory oversight if they meet certain requirements established by the statute. On February 28, 1992, regulations were published to implement CLIA. In the regulations, waived tests were defined as simple laboratory examinations and procedures that are cleared by the FDA for home use, employ methodologies that are so simple and accurate that mistakes are unlikely and negligible; or pose no reasonable risk of harm to the patient if performed incorrectly. To view the FDA listing of waived tests go to: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm The CLIA WAIVED products that we offer will be found under the Acon name. The cassettes were approved on 6/3/05 and the integrated cups on 9/13/05.
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