Urine Transport Kit (Excludes Hiv Testing)
The Urine Transport Kit (Excludes HIV Testing) is a convenience kit containing components for the collection and safe transport of urine specimens to a laboratory for clinical analysis, explicitly excluding HIV testing applications. Classified as FDA Class 1 under regulation 21 CFR 864.3250 within the Pathology 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) when all criteria are satisfied. The product code is OHZ. It is not flagged as an implant or life-sustaining device.
Research product code OHZ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OHZ
- Device Class
- FDA class 1
- Regulation Number
- 864.3250
- Medical Specialty
- Pathology
- 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 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.