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Title 21

Displaying title 21, up to date as of 7/09/2026. Title 21 was last amended 7/09/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 864Hematology and Pathology Devices864.1 – 864.9900
Subpart AGeneral Provisions864.1 – 864.9
§ 864.1Scope.
§ 864.3Effective dates of requirement for premarket approval.
§ 864.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart BBiological Stains864.1850 – 864.1880
§ 864.1850Dye and chemical solution stains.
§ 864.1860Immunohistochemistry reagents and kits.
§ 864.1865Cervical intraepithelial neoplasia (CIN) test system.
§ 864.1866Lynch syndrome test systems.
§ 864.1870Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.
§ 864.1880Fluorescence in situ hybridization (FISH)-based detection of chromosomal abnormalities from patients with hematologic malignancies.
Subpart CCell And Tissue Culture Products864.2220 – 864.2875
Subpart DPathology Instrumentation and Accessories864.3010 – 864.3875
Subpart ESpecimen Preparation Reagents864.4010 – 864.4400
§ 864.4010General purpose reagent.
§ 864.4020Analyte specific reagents.
§ 864.4400Enzyme preparations.
Subpart FAutomated and Semi-Automated Hematology Devices864.5200 – 864.5950
Subpart GManual Hematology Devices864.6100 – 864.6700
Subpart HHematology Kits and Packages864.7010 – 864.7925
Subpart IHematology Reagents864.8100 – 864.8950
Subpart JProducts Used In Establishments That Manufacture Blood and Blood Products864.9050 – 864.9875
Subpart KProducts Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)864.9900
§ 864.9900Cord blood processing system and storage container.