§ 884.6140 - Assisted reproduction micropipette fabrication instruments.

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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).