Device |
severe combined immunodeficiency disorder (scid) newborn screening test system |
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). |
Product Code | PJI |
Regulation Number |
866.5930
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Device Class |
2
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