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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 to 10 of 44 Results
Analyte hCG, Urine Complexity waived
 
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Document Analyte Analyte Specialty Effective Date
EGENS One Step HCG Urine Pregnancy Test Kit (Cassette)  
K123050 hCG, Urine Endocrinology 02/11/2013
EGENS One Step HCG Urine Pregnancy Test Kit (Midstream I)  
K123050 hCG, Urine Endocrinology 02/11/2013
EGENS One Step HCG Urine Pregnancy Test Kit (Midstream II)  
K123050 hCG, Urine Endocrinology 02/11/2013
EGENS One Step HCG Urine Pregnancy Test Kit (Strip)  
K123050 hCG, Urine Endocrinology 02/11/2013
SPD Swiss Precision Diagnostics GmbH Clearblue Advanced Pregnancy Test with Weeks Estimator  
K112870 hCG, Urine Endocrinology 12/11/2012
Alere San Diego Inc, Alere hCG Cassette (25 mIU/mL)  
K993317 hCG, Urine Endocrinology 01/11/2012
Alere San Diego Inc, Alere hCG Combo Cassette (20/10 mIU/mL)  
K062361 hCG, Urine Endocrinology 01/11/2012
Alere San Diego Inc, Alere hCG Combo Cassette (25 mIU/mL)  
K993065 hCG, Urine Endocrinology 01/11/2012
Alere San Diego Inc, Alere hCG Dipstick (25 mIU/mL)  
K993203 hCG, Urine Endocrinology 01/11/2012
Alere San Diego Inc. Alere hCG Cassette (20 mIU/mL)  
K062361 hCG, Urine Endocrinology 01/11/2012

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