Code of Federal Regulations · Section

§ 884.6140 — Assisted Reproduction Micropipette Fabrication Instruments

21 C.F.R. § 884.6140

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(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).

21 C.F.R. § 884.6130 21 C.F.R. § 884.6150

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