21 CFR § 864.6150 Hematology and Pathology Devices

§ 864.6150 Capillary blood collection tube.

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

(a) Identification. A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.

(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 60604, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 65 FR 2310, Jan. 14, 2000]

← § 864.6100 Bleeding time device.§ 864.6160 Manual blood cell counting device. →