Identity
- Trade Name
- VICTOR EnLite FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Device Name
- The VICTOR EnLite instrument is intended for the quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on a filter paper as an aid in screening newborns for severe combined immunodeficiency (SCID) using the polymerase chain reaction (PCR) based EnLite Neonatal TREC kit. FDA UDI
- Model / Reference
- 1420-0220 FDA UDI
- Description
- The VICTOR EnLite instrument is intended for the quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on a filter paper as an aid in screening newborns for severe combined immunodeficiency (SCID) using the polymerase chain reaction (PCR) based EnLite Neonatal TREC kit. FDA UDI
Identifiers
- Catalog Number
- 1420-0220 FDA UDI
- Primary DI / UDI-DI
- 06438147333202 FDA UDI
- FDA Product Code
- KHO FDA UDI
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2560 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
VICTOR EnLite by Wallac, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Wallac, Inc.
Sources (1)
- FDA UDI af068f2a-af77-4791-a0e0-48fc13985267 35 fields · synced May 30, 2026