StacksVerified U.S. regulatory reference

21 CFR §864.6160

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.
  2. (b)Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.