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U.S. Department of Health and Human Services

Medical Devices

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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
**
 
  • 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