DeviceClearance

Product code PJI— Immunology

Eonis SCID-SMA kit

Classification name
Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Device class
Class 2
Regulation
21 CFR 866.5930
Advisory panel
Immunology
Total cleared
2
First cleared
Most recent

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).”

— U.S. Food and Drug Administration, device classification record for product code PJI under 21 CFR 866.5930, via openFDA

Market context for product code PJI

FDA has cleared 2 devices under product code PJI between 2014 and 2022, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PJI

Recent clearances under product code PJI

Data sourced from openFDA. This site is unofficial and independent of the FDA.