U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
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All TitlesTitle 21Chapter IPart 864Subpart G - Subpart G—Manual Hematology Devices
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(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.
