Microscope And Microscope Accessories, Reproduction, Assisted
Assisted Reproduction Microscopes and Accessories are optical instruments and associated components specifically configured and validated for use in ART laboratories, used to examine oocytes, embryos, and sperm during IVF procedures. They are classified as FDA Class 1, subject only to general controls, with product code MTX under 21 CFR 884.6190 in the Obstetrics/Gynecology specialty. No premarket submission is required. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MTX
- Device Class
- FDA class 1
- Regulation Number
- 884.6190
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.