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21 CFR 884.6140

§ 884.6140 Assisted reproduction micropipette fabrication instruments.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 884.6140, § 884.6140 Assisted reproduction micropipette fabrication instruments, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90875
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(a) Identification. Assisted reproduction micropipette fabrication devices are instruments intended to pull, bevel, or forge a micropipette or needle for intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) or other similar assisted reproduction procedures. (b) Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.