21 CFR § 864.9600 - Potentiating media for in vitro diagnostic use.
---
identifier: "/us/cfr/t21/s864.9600"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.9600 - Potentiating media for in vitro diagnostic use."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.9600"
section_name: "Potentiating media for in vitro diagnostic use."
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"
---
# 864.9600 Potentiating media for in vitro diagnostic use.
(a) *Identification.* Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.
(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 § 864.9.
[45 FR 60649, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]