MTX · Microscope And Microscope Accessories, Reproduction, Assisted
Obstetrics/Gynecology · 21 CFR 884.6190 · Class 1
Overview
| Product Code | MTX |
|---|---|
| Device Name | Microscope And Microscope Accessories, Reproduction, Assisted |
| Regulation | 21 CFR 884.6190 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
Identification
Assisted reproduction microscopes and microscope accessories (excluding microscope stage warmers, which are classified under assisted reproduction accessories) are optical instruments used to enlarge images of gametes or embryos. Variations of microscopes and accessories used for these purposes would include phase contrast microscopes, dissecting microscopes and inverted stage microscopes.
Classification Rationale
Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Cleared Devices (0)
No cleared devices on record.
