PJIClass II
Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System
Immunology · 21 CFR 866.5930
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).
MDR events0All time
Recalls1All time
Registered firms2Currently listed
510(k) clearances2All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
2 firms currently registered for this product code
510(k) clearances
2 clearances for this product code