Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown