21 C.F.R. § 864.9185

Blood grouping view box.

Last amended: 2016Year: 2026Length: 76 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 864.9185 (2026)

(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]
Cross-references to the CFR
864.9.
21 C.F.R. § 864.9185: Blood grouping view box. | Justis AI