Medical Devices

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

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:

Document_Numbe r| Test_System _ID | Test_System_Name | Qualifier 1 | Qualifier 2 ] Analyte_ID | Analyte_Name | Speciality_ID
| Complexity | Date_Effective

Page Last Updated: 10/30/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.