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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Analyte Urine hCG By Visual Color Comparison Tests Complexity waived
 
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BTNX, Inc. Rapid Response At-Home Pregnancy Test  
K122907 Urine hCG By Visual Color Comparison Tests Endocrinology 05/14/2013
BTNX Rapid Response hCG Pregnancy Serum/Urine Combo Test  
K112101 Urine hCG By Visual Color Comparison Tests Endocrinology 04/19/2013
Healgen hCG One Step Pregnancy Test strip  
K123703 Urine hCG By Visual Color Comparison Tests Endocrinology 04/16/2013
Healgen hCG One Step Pregnancy Test Cassette  
K123703 Urine hCG By Visual Color Comparison Tests Endocrinology 04/16/2013
Polymed Therapeutics Fastep At-Home Pregnancy Test  
K122907 Urine hCG By Visual Color Comparison Tests Endocrinology 03/25/2013
Tianjin New Bay Bioresearch Co., Ltd. QuikResponse One Step Midstream Early Pregnancy Test  (for home use)
K112449 Urine hCG By Visual Color Comparison Tests Endocrinology 01/30/2013
Moore Medical, Mooremedical hCG Serum/Urine Test-Cassette  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 09/25/2012
Moore Medical, Mooremedical hCG Urine -Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 09/25/2012
Moore Medical, Mooremedical hCG Urine-Cassette  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 09/25/2012
Polymed Therapeutics Fastep hCG Pregnancy Serum/Urine Combo Test  
K112101 Urine hCG By Visual Color Comparison Tests Endocrinology 07/17/2012

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