Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing)
The Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes HIV Testing) is a convenience kit containing materials for the collection, preservation, and labeling of forensic evidence from victims or suspects involved in sexual assault or sex crimes, explicitly excluding HIV testing components. Classified as FDA Class 1 under regulation 21 CFR 866.2900 within the Microbiology medical specialty, it is under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance and does not require a 510(k). The product code is OID. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OID
- Device Class
- FDA class 1
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Review Panel
- CH
- 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.