21 CFR § 862.1675 - Blood specimen collection device.

---
identifier: "/us/cfr/t21/s862.1675"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1675 - Blood specimen collection device."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1675"
section_name: "Blood specimen collection device."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY 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."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 862.1675 Blood specimen collection device.

(a) *Identification.* A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

(b) *Classification.* Class II.