---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchH/part864"
level: "part"
label: "Part 864"
heading: "Hematology and Pathology Devices"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchH-part864"
sections_count: 126
---

# Part 864 — Hematology and Pathology Devices

Title 21 C.F.R. — Food and Drugs › Chapter I — Food and Drug Administration, Department of Health and Human Services › Subchapter H — Medical Devices

## Contents

- [Subpart A — General Provisions](/cfr/21/chI-subchH-part864-subpartA.md)
- [Subpart B — Biological Stains](/cfr/21/chI-subchH-part864-subpartB.md)
- [Subpart C — Cell And Tissue Culture Products](/cfr/21/chI-subchH-part864-subpartC.md)
- [Subpart D — Pathology Instrumentation and Accessories](/cfr/21/chI-subchH-part864-subpartD.md)
- [Subpart E — Specimen Preparation Reagents](/cfr/21/chI-subchH-part864-subpartE.md)
- [Subpart F — Automated and Semi-Automated Hematology Devices](/cfr/21/chI-subchH-part864-subpartF.md)
- [Subpart G — Manual Hematology Devices](/cfr/21/chI-subchH-part864-subpartG.md)
- [Subpart H — Hematology Kits and Packages](/cfr/21/chI-subchH-part864-subpartH.md)
- [Subpart I — Hematology Reagents](/cfr/21/chI-subchH-part864-subpartI.md)
- [Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products](/cfr/21/chI-subchH-part864-subpartJ.md)
- [Subpart K — Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)](/cfr/21/chI-subchH-part864-subpartK.md)