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Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

FDA product code PJI · 1 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5930
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2022-11-09 – 2022-11-09

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).

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