PJI

Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

Product code

PJI

Device name

Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

Device class

Class 2

21 CFR

21 CFR 866.5930

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).