Find Device CLIA '88 Categorization

The CLIA Database lists records of all commercially marketed in vitro test systems that FDA has categorized under the Clinical Laboratory Improvement Amendments (CLIA '88) since January 31, 2000. It contains all tests categorized by the Centers for Disease Control and Prevention (CDC) before that date. You can search the CLIA Database by:

• test system name
• analyte name
• complexity
• specialty
• date of categorization.

Many of the records contain links to:

• 510(k) summary or
• PMA summary of safety and effectiveness.

FDA updates the CLIA database monthly.