CLIA Categories and Subcategories

70.5 - CLIA Categories and Subcategories (Rev. 11463; Issued: 06-23-22; Effective: 07-25-22; Implementation: 07-25-22) A laboratory may be licensed or exempted from licensure in several major categories of procedures. These major categories are: Category Number Category/Subcategory Name 010 Histocompatibility 100 Microbiology 110 Bacteriology 115 Mycobacteriology 120 Mycology 130 Parasitology 140 Virology 150 Other Microbiology 200 Diagnostic Immunology 210 Syphilis Serology Category Number Category/Subcategory Name 220 General Immunology 300 Chemistry 310 Routine 320 Urinalysis 330 Endocrinology 340 Toxicology 350 Other 400 Hematology 500 Immuno-hematology 510 ABO Group and RH Type 520 Antibody Detection (Transfusion) 530 Antibody Detection (Non Transfusion) 540 Antibody Identification 550 Compatability Testing 560 Other 600 Pathology 610 Histopathology 620 Oral Pathology 630 Cytology 800 Radioassay 900 Clinical Cytogenics Information regarding CLIA test complexity categorization can be found by searching the U.S. Food and Drug Administration website (www.fda.gov).