Panels › Immunology › Product code PJI · Class 2
Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Regulation 866.5930
0510(k)s in 12 months (2 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in PJI
| Company | 510(k)s | Recalls |
|---|---|---|
| Perkinelmer, Inc. | 1 | 0 |
| PerkinElmer Health Sciences, Inc. | 0 | 1 |
| Wallac OY | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2016 | PerkinElmer Health Sciences, Inc. EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test Terminated |
PJI | None listed |
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