21 CFR 884.6130 — Microtools, Assisted Reproduction (Pipettes)
Obstetrics/Gynecology (OB) · Part 884 Subpart G—Assisted Reproduction Devices · § 884.6130
Identification
Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.
Classification Rationale
Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MQH | Microtools, Assisted Reproduction (Pipettes) | 2 | 26 | 3rd Party |
| PUC | Microtools, Assisted Reproduction (Pipettes), Exempt | 2 | 0 |
Special Controls
MQH — Microtools, Assisted Reproduction (Pipettes)
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
eCFR
MQH — Microtools, Assisted Reproduction (Pipettes)
mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing
Ecfr Llm
PUC — Microtools, Assisted Reproduction (Pipettes), Exempt
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
eCFR
