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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Analyte Opiates Complexity waived
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Document Analyte Analyte Specialty Effective Date
WayPoint Biomedical Inc, Health Essist Multi-Drug Home Drug Test Cup  
K050878 Opiates Toxicology / TDM 08/21/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
K040629 Opiates Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Opiates Toxicology / TDM 06/15/2006
Noble Medical Inc. Split-Specimen Cup  
K050878 Opiates Toxicology / TDM 04/19/2006
Biotechnostix, Inc. Rapid Response One Step Multi-Drug, Multi-Line Screen Test Device  
K050050 Opiates Toxicology / TDM 03/03/2006
Biotechnostix Rapid Response Multi-Drug, Multi-Line Screen Test Card with Integrated Cup  
K050878 Opiates Toxicology / TDM 02/27/2006
First Check Diagnostics First Check 12 Drug Test  
K052115 Opiates Toxicology / TDM 02/22/2006
First Check Diagnostics First Check Multi Drug Cup  
K051966 Opiates Toxicology / TDM 01/17/2006
First Check Multi Drug Cup 12  (OTC)
K052115 Opiates Toxicology / TDM 01/10/2006
Worldwide Medical First Check Multi Drug Cup 7  (OTC)
K051966 Opiates Toxicology / TDM 11/29/2005

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