21 CFR 884.6140 — Microtool Fabrication, Assisted Reproduction
Obstetrics/Gynecology (OB) · Part 884 Subpart G—Assisted Reproduction Devices · § 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 Rationale
Class II (special controls) (design specifications, labeling requirements, and clinical testing).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MQI | Microtool Fabrication, Assisted Reproduction | 2 | 0 | 3rd Party |
Special Controls
MQI — Microtool Fabrication, Assisted Reproduction
*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing).
eCFR
MQI — Microtool Fabrication, Assisted Reproduction
design specifications, labeling requirements, and clinical testing
Ecfr Llm
