21 C.F.R. § 884.6140 Assisted reproduction micropipette fabrication instruments.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart G—Assisted Reproduction Devices
§ 884.6140 Assisted reproduction micropipette fabrication instruments.
