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Cllinical Laboratory Improvement Amendments - Download Data

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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
33 Bacteriology
34 Cytology
35 Endocrinology
36 General Chemistry
37 General Immunology
38 Hematology
39 Immunohematology
40 Mycobacteriology
41 Mycology
42 Parasitology
43 Toxicology/TDM
44 Urinalysis
45 Virology
46 Unknown

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

Updated 5/22/2002

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