CLIA - Clinical Laboratory Improvement Amendments

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Document	Analyte	Analyte Specialty	Effective Date
Physicians' Test Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	07/04/2010
QuikTest USA, Inc. Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	07/04/2010
Screen Tox Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	07/04/2010
Total Diagnostic Solutions Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	07/04/2010
Ameditech, Inc ImmuTest Drug Screen Cup
K052115	Barbiturates	Toxicology / TDM	07/01/2010
MedDirect, Inc Multiple Drug Screen Cups
K091588	Barbiturates	Toxicology / TDM	06/03/2010
MedDirect, Inc ProXam Drug Test Cards
K091588	Barbiturates	Toxicology / TDM	06/03/2010
US Diagnostics ProScreen Drugs of Abuse Cup (OTC)
K052115	Barbiturates	Toxicology / TDM	05/10/2010
Instant Technologies, iCup Dx Drug Screen Cup
K052115	Barbiturates	Toxicology / TDM	05/06/2010
Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test
K063545	Barbiturates	Toxicology / TDM	05/03/2010