§884.6140. Assisted reproduction micropipette fabrication instruments.
21 C.F.R. § 884.6140
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.
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing).
Notes, amendments, and revision history
Source
Source: 63 FR 48436, Sept. 10, 1998, unless otherwise noted.
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.