Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
PJI is the FDA product code for Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System, a class II device type, regulated under 21 CFR 866.5930. FDA's definition for this code reads: "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)". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- PJI
- Device name
- Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
- 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).
- Regulation
- 21 CFR 866.5930
- Device class
- Class II
- Review panel
- Immunology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 2
- Ingested recalls
- 1
Clearances, product code PJI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2022 | 1 |
Applicants with the most clearances
Product code PJI| Applicant | Clearances |
|---|---|
| Revvity Health Sciences, Inc. | 1 |
| Wallac Oy | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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