CLIA - Clinical Laboratory Improvement Amendments

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Analyte Methylenedioxymethamphetamine (MDMA) Complexity waived

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Document	Analyte	Analyte Specialty	Effective Date
Alere iScreen DX Multi-Drugs of Abuse Dip Test
K040203	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/29/2013
Alere iScreen DX Single Dip Card
K040203	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/29/2013
Cliawaived Inc. Drug of Abuse Card
K122904	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/29/2013
Cliawaived Inc. Instant Drug Test Cup
K122904	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/29/2013
US Diagnostics Inc. Uscreen Drug of Abuse Cup
K130665	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/29/2013
US Diagnostics Inc. UScreen Drugs of Abuse Card
K130665	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/29/2013
Alere Toxicology Services, Inc. Tox Screen Drugs of Abuse Test Cup (Professional Use)
K050878	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	05/17/2013
American Screening Corporation Discover Drug Test Cards
K123863	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	02/27/2013
American Screening Corporation Discover Multi-Panel Drug Test Cups
K123863	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	02/27/2013
Branan Medical Corporation ToxCup Drug Screen Cup (Cassette Dip Card format)
K122633	Methylenedioxymethamphetamine (MDMA)	Toxicology / TDM	02/08/2013