Others titles

  • CLIA Datasets
  • Clinical Laboratory Improvement Amendments (CLIA)

Keywords

  • CLIA
  • Laboratory Tests
  • Marketed Laboratory Tests
  • CLIA Database
  • Laboratory Testing
  • Quality Laboratory Testing

Clinical Laboratory Improvement Amendments

The CLIA Database lists records of all commercially marketed laboratory tests that have been categorized under the Clinical Laboratory Improvement Amendments (CLIA), either by the Centers for Disease Control and Prevention (CDC) prior to January 31, 2000 or by the FDA since that date.

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Description

The Clinical Laboratory Improvement Amendments (CLIA) Dataset includes records of all commercially marketed laboratory tests categorized by CDC or FDA.
For each Document Number that refers to 510(k), Premarket approval (PMA), humanitarian device exemption (HDE) or 510(k) exempt number, a Parent Number, Analyte Id and name, a Test System Id and the Specialty Id are listed.

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.
Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control (CDC). Each agency has a unique role in assuring quality laboratory testing.

About this Dataset

Data Info

Date Created

2013

Last Modified

2018-12-24

Version

2018-12-24

Update Frequency

Quarterly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

CLIA, Laboratory Tests, Marketed Laboratory Tests, CLIA Database, Laboratory Testing, Quality Laboratory Testing

Other Titles

CLIA Datasets, Clinical Laboratory Improvement Amendments (CLIA)

Data Fields

Name Description Type Constraints
Document_NumberDocument Number refers to either the 510(k), Premarket approval (PMA), humanitarian device exemption (HDE) or 510(k) exempt numberstringrequired : 1
Test_System_idThe Test System Id is an internally generated number based on the test system, analyte and categorizationintegerlevel : Nominalrequired : 1
Test_System_NameTest System Namestringrequired : 1
Qualifier1The qualifier field is to expand on the test system for using another manufacturer's reagent on the test system and/or an additional processing step.string-
Qualifier2The qualifier field is to expand on the test system for using another manufacturer's reagent on the test system and/or an additional processing step.string-
Analyte_idThe Analyte ID is an internally generated numberintegerlevel : Nominalrequired : 1
Analyte_NameAnalyte Namestringrequired : 1
Specialty_idThe Speciality_ID field contains codes that translate to the following Speciality Names:integerlevel : Nominalrequired : 1
ComplexityComplexity of the diagnostic teststringenum : Array ( [0] => MODERATE [1] => HIGH [2] => WAIVED ) required : 1
Date_EffectiveEffective date of the categorizationdaterequired : 1

Data Preview

Document NumberTest System idTest System NameQualifier1Qualifier2Analyte idAnalyte NameSpecialty idComplexityDate Effective
X14000521528Carolina Liquid Chemistries Corp., Biolis 24i clinical chemistry analyzer12Alanine aminotransferase (ALT) (SGPT)2MODERATE2014-03-18
X14000322432RightBio Metrics, RightSpot Infant pH Indicator335Gastric pH2WAIVED2014-03-18
X14000322433RightBio Metrics, RightLevel pH Detector335Gastric pH2WAIVED2014-03-18
X14000322434RightBio Metrics, RightSpot pH Indicator335Gastric pH2WAIVED2014-03-18
X14000214778Vital Diagnostics, Envoy 500 Chemistry Analyzer7Protein, total2MODERATE2014-02-25
X14000114778Vital Diagnostics, Envoy 500 Chemistry Analyzer8Lactate dehydrogenase (LDH)2MODERATE2014-02-25
X13003322319The Binding Site Spaplus Analyzer5Albumin2MODERATE2014-01-28
X13003222235Bio-Rad Laboratories Inc., UriSelect™ 4 MediumFor Isolation and Differentiation of Urinary Tract Pathogens142Aerobic organisms from urine specimens only8HIGH2013-12-13
X13003222236Bio-Rad Laboratories Inc., UriSelect™ 4 MediumFor Enumeration of Urinary Tract Pathogens142Aerobic organisms from urine specimens only8MODERATE2013-12-13
X13002922116Carolina Liquid Chemistries CLC 720 Chemistry Analyzer842Gamma glutamyl transferase (GGT)2MODERATE2013-11-07