21 CFR 884.6140 - Assisted reproduction micropipette fabrication instruments.

Regulations last checked for updates: May 03, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

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