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)

Name	Description	Type	Constraints
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

Document_Number	Test_System_id	Test_System_Name	Qualifier1	Qualifier2	Analyte_id	Analyte_Name	Specialty_id	Complexity	Date_Effective
K943702	6338	AVL 988-4			134	pH	2	MODERATE	1994-10-14
CDC000005	9091	AVL 940			134	pH	2	MODERATE	1993-07-26
CDC000005	9092	AVL 947			134	pH	2	MODERATE	1993-07-26
CDC000005	9093	AVL 990			134	pH	2	MODERATE	1993-07-26
CDC000005	9094	AVL 995			134	pH	2	MODERATE	1993-07-26
CDC000005	9107	AVL 945			134	pH	2	MODERATE	1993-07-26
K944089	6352	AVL OPTI 1			134	pH	2	MODERATE	1995-01-20
K924547	5472	Nova 8			137	Sodium	2	MODERATE	1993-11-22
CDC000005	9091	AVL 940			136	PO2	2	MODERATE	1993-07-26
CDC000005	9092	AVL 947			136	PO2	2	MODERATE	1993-07-26

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Clinical Laboratory Improvement Amendments

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