21 CFR 884.6140 - Assisted reproduction micropipette fabrication instruments.

Regulations last checked for updates: Feb 13, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart G [§ 884.6100 - § 884.6200]

§ 884.6140 - Assisted reproduction micropipette fabrication instruments.

(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).

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

cite as: 21 CFR 884.6140