- CLIA Datasets
- Clinical Laboratory Improvement Amendments (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.
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
John Snow Labs; U.S. Food and Drug Administration (FDA);
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CLIA, Laboratory Tests, Marketed Laboratory Tests, CLIA Database, Laboratory Testing, Quality Laboratory Testing
CLIA Datasets, Clinical Laboratory Improvement Amendments (CLIA)
|Document_Number||Document Number refers to either the 510(k), Premarket approval (PMA), humanitarian device exemption (HDE) or 510(k) exempt number||string||required : 1|
|Test_System_id||The Test System Id is an internally generated number based on the test system, analyte and categorization||integer||required : 1 level : Nominal|
|Test_System_Name||Test System Name||string||required : 1|
|Qualifier1||The 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||-|
|Qualifier2||The 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_id||The Analyte ID is an internally generated number||integer||required : 1 level : Nominal|
|Analyte_Name||Analyte Name||string||required : 1|
|Specialty_id||The Speciality_ID field contains codes that translate to the following Speciality Names:||integer||required : 1 level : Nominal|
|Complexity||Complexity of the diagnostic test||string||enum : Array required : 1|
|Date_Effective||Effective date of the categorization||date||required : 1|
|K944089||6352||AVL OPTI 1||134||pH||2||MODERATE||1995-01-20|