FDA 21 CFR Part 864 Hematology and Pathology Devices

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Table of contents

Subpart A - General Provisions

864.1 Scope.

864.3 Effective dates of requirement for premarket approval.

864.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B - Biological Stains

864.1850 Dye and chemical solution stains.

864.1860 Immunohistochemistry reagents and kits.

864.1865 Cervical intraepithelial neoplasia (CIN) test system.

864.1866 Lynch syndrome test systems.

864.1870 Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.

Subpart C - Cell And Tissue Culture Products

864.2220 Synthetic cell and tissue culture media and components.

864.2240 Cell and tissue culture supplies and equipment.

864.2260 Chromosome culture kit.

864.2280 Cultured animal and human cells.

864.2360 Mycoplasma detection media and components.

864.2800 Animal and human sera.

864.2875 Balanced salt solutions or formulations.

Subpart D - Pathology Instrumentation and Accessories

864.3010 Tissue processing equipment.

864.3250 Specimen transport and storage container.

864.3260 OTC test sample collection systems for drugs of abuse testing.

864.3300 Cytocentrifuge.

864.3600 Microscopes and accessories.

864.3700 Whole slide imaging system.

864.3800 Automated slide stainer.

864.3875 Automated tissue processor.

Subpart E - Specimen Preparation Reagents

Subpart F - Automated and Semi-Automated Hematology Devices

Subpart G - Manual Hematology Devices

Subpart H - Hematology Kits and Packages

Subpart I - Hematology Reagents

Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products, (and)

Subpart K - Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

FDA 21 CFR Part 864 Hematology and Pathology Devices: