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Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

FDA product code PJI · Class 2 · Immunology

5
Registered devices
0
Adverse events
1
Recalls
2
510(k) clearances

Devices with this code

Eonis SCID-SMA kit — Wallac OyEnLite Neonatal TREC kit — Wallac OyEnLite Neonatal TREC kit — Wallac OyEonis SCID-SMA kit — Wallac OyEnLite Neonatal TREC kit — Wallac Oy

Recent recalls

DateFirmReason
2016-12-05PerkinElmer Health Sciences, Inc.Unique Device Identifier (UDI) is missing from outer kit box label.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.