Clinical Laboratory Improvement Amendments

$447.50 / year

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.

Complexity

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.

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)

NameDescriptionTypeConstraints
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 categorizationintegerrequired : 1 level : Nominal
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 numberintegerrequired : 1 level : Nominal
Analyte_NameAnalyte Namestringrequired : 1
Specialty_idThe Speciality_ID field contains codes that translate to the following Speciality Names:integerrequired : 1 level : Nominal
ComplexityComplexity of the diagnostic teststringenum : Array required : 1
Date_EffectiveEffective date of the categorizationdaterequired : 1
Document_NumberTest_System_idTest_System_NameQualifier1Qualifier2Analyte_idAnalyte_NameSpecialty_idComplexityDate_Effective
K9437026338AVL 988-4134pH2MODERATE1994-10-14
CDC0000059091AVL 940134pH2MODERATE1993-07-26
CDC0000059092AVL 947134pH2MODERATE1993-07-26
CDC0000059093AVL 990134pH2MODERATE1993-07-26
CDC0000059094AVL 995134pH2MODERATE1993-07-26
CDC0000059107AVL 945134pH2MODERATE1993-07-26
K9440896352AVL OPTI 1134pH2MODERATE1995-01-20
K9245475472Nova 8137Sodium2MODERATE1993-11-22
CDC0000059091AVL 940136PO22MODERATE1993-07-26
CDC0000059092AVL 947136PO22MODERATE1993-07-26