Forensic Evidence Sexual Assault Kit
The Forensic Evidence Sexual Assault Kit is a convenience kit containing components for the collection, preservation, and documentation of forensic evidence in the examination of sexual assault patients. Classified as FDA Class 2 under regulation 21 CFR 884.1630 within the Obstetrics/Gynecology medical specialty, it is subject to enforcement discretion under the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k) when all criteria are met. The product code is OHE. It is not designated as an implant or life-sustaining device.
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Basic Information
- Product Code
- OHE
- Device Class
- FDA class 2
- Regulation Number
- 884.1630
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.