Find Device CLIA '88 Categorization

The CLIA '88 database lists all commercially marketed in vitro test systems that FDA has categorized under the Clinical Laboratory Improvement Amendments (CLIA '88) since January 31, 2000. It also contains all tests categorized by the Centers for Disease Control and Prevention (CDC) prior to that date. You can search the CLIA '88 database by test system name, analyte name, complexity, specialty, or date of categorization. Many of the records also contain links to the 510(k) summary or the PMA summary of safety and effectiveness. FDA updates this database monthly.

• Search the CLIA '88 Database
• List of Tests Waived by FDA
• List of Currently Waived Analytes
• Good Laboratory Practices for CLIA Waived Testing Sites

For questions about CLIA '88 categorization, contact CLIA@CDRH.FDA.GOV.

See also: CLIA '88 - Clinical Laboratory Improvement Amendments