FDA Product Code PJI: Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System
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).
Leading manufacturers include Perkinelmer, Inc..
2
Total
1
Cleared
532d
Avg days
2014
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System Devices (Product Code PJI)
2 devices
About Product Code PJI - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code PJI since 2014, with 1 receiving FDA clearance (average review time: 532 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.