Clinical Laboratory Improvement Amendments - Download Data

You can download a CLIA file of in vitro test systems that have been categorized by the FDA and import into a local database program.

Each field is delimited or separated by a "pipe" and are as follows:

Document Number	(refers to either the 510(k), PMA, HDE or 510(k) exempt number)
Test_System_ID	(An internally generated number based on the test system, analyte and categorization)
Test_System_Name
Qualifer1	(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.)
Qualifer2	(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.)
Analyte_ID	(Internally generated number)
Analyte_Name
Speciality_ID	**
Complexity
Date_Effective	(Effective date of the categorization)

The Speciality_ID field contains codes that translate to the following Speciality Names:

Speciality_ID	Speciality_Name
1	Urinalysis
2	General Chemistry
3	General Immunology
4	Hematology
5	Immunohematology
6	Endocrinology
7	Toxicology/TDM
8	Bacteriology
9	Mycobacteriology
10	Virology
11	Parasitology
12	Mycology
13	Cytology

Test systems categorized by the CDC prior to February 2, 2000 are also are available for download as a separate file. The Zip file is 338 KB and has 25713 records. The records are pipe, "|" delimitted and the first line of data consists of the column names as follows: