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:
| (refers to either the 510(k), PMA, HDE or 510(k) exempt number) |
| (An internally generated number based on the test system, analyte and categorization) |
| |
| (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.) |
| (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.) |
| (Internally generated number) |
| |
| ** |
| (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:
Document_Numbe r| Test_System _ID | Test_System_Name | Qualifier 1 | Qualifier 2 ] Analyte_ID | Analyte_Name | Speciality_ID
| Complexity | Date_Effective