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Culture, Intravaginal, Assisted Reproduction

FDA product code OYO · 1 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 884.6165
Review panel
OB
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-06-22 – 2023-06-22

Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period.

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