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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 884 - Obstetrical and Gynecological Devices |
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Subpart G - Assisted Reproduction Devices |
§ 884.6140 - Assisted reproduction micropipette fabrication instruments.
Latest version.
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§ 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).