PJI — Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System Class II
FDA product code PJI covers "Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System", a Class II medical device regulated under 21 CFR 866.5930. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PJI
- Device Class
- Class II
- Regulation Number
- 866.5930
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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).