21 CFR § 864.9185 Hematology and Pathology Devices

§ 864.9185 Blood grouping view box.

Current through Sep 8, 2026 · Read all of Part 864

(a) Identification. A blood grouping view box is a device with a glass or plastic viewing surface, which may be illuminated and heated, that is used to view cell reactions in antigen-antibody testing.

(b) Classification. Class I (general 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 60641, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]

← § 864.9175 Automated blood grouping and antibody test system.§ 864.9195 Blood mixing devices and blood weighing devices. →