Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)
The Neonatal Blood Collection Kit and Screening Form (Excludes HIV Testing) is a convenience kit containing components for collecting blood specimens from newborns along with the associated screening documentation form, used for neonatal metabolic and genetic screening programs, excluding HIV testing. 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). The product code is OIA. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OIA
- 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 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.