# Blood And Urine Collection Kit (Excludes Hiv Testing)
> **Product code: OIB** · Class I — Low Risk (general controls) · Pathology · 21 CFR 864.3250
## Classification
- **FDA Product Code:** OIB
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 864.3250
- **Review panel:** CH
- **Medical specialty:** Pathology
- **Submission type:** 7
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 42
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OIB)
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