---
kind: "section"
citation: "21 C.F.R. § 884.6140"
title: "21"
number: "884.6140"
heading: "Assisted reproduction micropipette fabrication instruments."
url: "https://uscodex.org/cfr/21/884.6140"
---

# §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).

## Notes

### 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.