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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 01/31/2015
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Document Parent Analyte Analyte Specialty Effective Date
Diagnostics Direct LLC Syphilis Health Check  (Fingerstick Whole Blood Only)
CW140011 K102400 Treponema pallidum (syphilis) antibodies Bacteriology 12/15/2014
Transmetron Invitro Pro Drug Test Cups  
CR140470 K131811 Amphetamines Toxicology / TDM 12/10/2014
Transmetron Invitro Pro Drug Test Cups  
CR140470 K131811 Phencyclidine (PCP) Toxicology / TDM 12/10/2014
Transmetron Invitro Pro Drug Test Cups  
CR140470 K131811 Propoxyphene Toxicology / TDM 12/10/2014
Transmetron Invitro Pro Drug Test Cups  
CR140470 K131811 Methamphetamines Toxicology / TDM 12/10/2014
Transmetron Invitro Pro Drug Test Cups  
CR140470 K131811 Morphine Toxicology / TDM 12/10/2014
Transmetron Invitro Pro Drug Test Cups  
CR140470 K131811 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/10/2014
Transmetron Invitro Pro Drug Test Cups  
CR140470 K131811 Buprenorphine Toxicology / TDM 12/10/2014
Coastline Medical Management Coastline Explorer Cup  (Cassette Dip Card format)
CR140449 K122633 Amphetamines Toxicology / TDM 12/10/2014
Coastline Medical Management Coastline Explorer Cup  (Cassette Dip Card format)
CR140449 K122633 Phencyclidine (PCP) Toxicology / TDM 12/10/2014

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