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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte pH Complexity waived Effective Date To 07/30/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Healgen MOP One Step Morphine Test Strip  
CR140231 K141647 Morphine Toxicology / TDM 07/18/2014
Healgen MOP One Step Morphine Test Cassette  
CR140231 K141647 Morphine Toxicology / TDM 07/18/2014
Healgen MOP One Step Morphine Test Dip Card  
CR140231 K141647 Morphine Toxicology / TDM 07/18/2014
Healgen MOP One Step Morphine Test Cup  
CR140231 K141647 Morphine Toxicology / TDM 07/18/2014
Ekla Corporation NOVAPLUS MDMA and OPI Drug Test Cup  {Urine} (Cup format)
CR140225 K130275 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/16/2014
Guangzhou Wondfo Biotech Co., Ltd CR3 Keyless Split Sample Cup Amphetamine-Cocaine  
CR140224 K141532 Amphetamines Toxicology / TDM 07/15/2014
Elka Corporation NOVAPLUS Drug Test Cup  
CR140220 K071489 Amphetamines Toxicology / TDM 07/15/2014
Elka Corporation NOVAPLUS Drug Test Cup  
CR140220 K071489 Phencyclidine (PCP) Toxicology / TDM 07/15/2014
Elka Corporation NOVAPLUS Drug Test Cup  
CR140220 K071489 Methamphetamines Toxicology / TDM 07/15/2014
Elka Corporation NOVAPLUS Drug Test Cup  
CR140220 K071489 Morphine Toxicology / TDM 07/15/2014

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