FDA product code OYB
Kit, Rna Detection, Human Papillomavirus
UnknownClass 321 CFR
US regulatory classifications
- US Risk Class (FDA)
- Class 3
- Medical specialty
- Unknown
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
For the detection of human papillomavirus RNA to aid in assessing risk of cancer.
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About this record
Kit, Rna Detection, Human Papillomavirus is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.