Identity
- Trade Name
- EnLite Neonatal TREC kit FDA UDI
- Generic Name
- T-cell receptor excision circle (TREC) IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dried blood specimens. FDA UDI
- Model / Reference
- 3401-001U FDA UDI
- Description
- Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dried blood specimens. FDA UDI
Identifiers
- Catalog Number
- 3401-001U FDA UDI
- Primary DI / UDI-DI
- 06438147331802 FDA UDI
- 510(k) Number
- DEN140010 FDA UDI
- FDA Product Code
- PJI FDA UDI
- GMDN Term
- T-cell receptor excision circle (TREC) IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5930 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: T-cell receptor excision circle (TREC) IVD, kit, nucleic acid technique (NAT)
EnLite Neonatal TREC kit by Wallac, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as T-cell receptor excision circle (TREC) IVD, kit, nucleic acid technique (NAT).
- EnLite Neonatal TREC kit — Wallac, Inc. · Class II
- EnLite Neonatal TREC kit — Wallac, Inc. · Class II
Cleared under the same submission
DEN140010 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Wallac, Inc.
Sources (1)
- FDA UDI 558bfbeb-a479-41e4-a083-bc08323f596a 36 fields · synced Jun 8, 2026