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
14	Cytogenetics
15	Histocompatibility
16	Pathology
17	Syphilis Serology

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: