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EnLite Neonatal TREC kit

Wallac Oy · Model 3401-001U · UDI-DI 06438147331802

PJI Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
1
Facilities

Description

Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dried blood specimens.

Recalls

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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.