Blood Specimen Collection Kit (Excludes Hiv Testing)
The Blood Specimen Collection Kit (Excludes HIV Testing) is a convenience kit assembled with components for the collection of blood specimens for laboratory analysis, explicitly excluding HIV testing applications. It is classified as FDA Class 1 under regulation 21 CFR 868.1100 within the Anesthesiology medical specialty, subject only to general controls, and falls under the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, exempting it from 510(k) requirements when all criteria are satisfied. The product code is OFZ. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OFZ
- Device Class
- FDA class 1
- Regulation Number
- 868.1100
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- 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 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.