# Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
> **Product code: PJI** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5930
## Classification
- **FDA Product Code:** PJI
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5930
- **Review panel:** IM
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper.  It is intended as an aid in screening newborns for severe combined immunodeficiency (SCID).

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PJI)
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