PJI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5930
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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).
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Eonis SCID-SMA kit (K203035) | Perkinelmer, Inc. | 2022-11-09 |
| PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM (DEN140010) | Wallac OY | 2014-12-15 |
Track PJI automatically
Every clearance here is in the API, with alerts when new ones post.