21 CFR § 864.8165 - Calibrator for hemoglobin or hematocrit measurement.
---
identifier: "/us/cfr/t21/s864.8165"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.8165 - Calibrator for hemoglobin or hematocrit measurement."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.8165"
section_name: "Calibrator for hemoglobin or hematocrit measurement."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---
# 864.8165 Calibrator for hemoglobin or hematocrit measurement.
(a) *Identification.* A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.
(b) *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
[45 FR 60632, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]