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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Thyroid stimulating hormone (TSH) Complexity waived Effective Date To 09/23/2014
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Document Parent Analyte Analyte Specialty Effective Date
Germaine Laboratories, Inc. AimStep Thyroid Screen  (whole blood)
CR140109 K030912 Thyroid stimulating hormone (TSH) Endocrinology 05/16/2014
BTNX Rapid Response Thyroid Stimulating Hormone (TSH) Test Cassette (Whole Blood)  
K030912   Thyroid stimulating hormone (TSH) Endocrinology 03/01/2013
Pharmaceutical Marketing Systems, Inc., Thyrotest Whole Blood TSH Test  
K030912   Thyroid stimulating hormone (TSH) Endocrinology 12/11/2012
BTNX, Inc Rapid Response Thyroid Stimulating Hormone (TSH) Test Cassette  (whole blood)
K990658   Thyroid stimulating hormone (TSH) Endocrinology 03/04/2010
Aventir Biotech LLC, FORSURE TSH test  (whole blood)
K990658   Thyroid stimulating hormone (TSH) Endocrinology 03/02/2010
CLIAwaived INC. Thyroid Test Rapid TSH Cassette  (whole blood)
K990658   Thyroid stimulating hormone (TSH) Endocrinology 06/03/2009
Qualigen, Inc. FastChek TSH  (whole blood)
K990658   Thyroid stimulating hormone (TSH) Endocrinology 02/29/2008
Jant Pharmacal Corporation Accutest TSH  (whole blood)
K990658   Thyroid stimulating hormone (TSH) Endocrinology 04/02/2007
Little Nell Labs ThyroChek TSH   (whole blood)
K990658   Thyroid stimulating hormone (TSH) Endocrinology 10/04/2006
THYROTEC INC. THYROTEST WHOLE BLOOD TSH TEST  
K030912   Thyroid stimulating hormone (TSH) Endocrinology 08/18/2004

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