VICTOR EnLite 1420-0220

GUDID 06438147333202

The VICTOR EnLite instrument is intended for the quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on

Wallac Oy

Fluorescent immunoassay analyser IVD, laboratory, semi-automated

• Primary Device ID: 06438147333202
• NIH Device Record Key: af068f2a-af77-4791-a0e0-48fc13985267
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VICTOR EnLite
• Version Model Number: 1420-0220
• Catalog Number: 1420-0220
• Company DUNS: 540156544
• Company Name: Wallac Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438147333202 [Primary]

FDA Product Code

• KHO: Fluorometer, For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-27
• Device Publish Date: 2019-03-19

On-Brand Devices [VICTOR EnLite]

• 06438147333219: The VICTOR EnLite instrument is intended for the quantitative determination of TREC (T-cell rece
• 06438147333202: The VICTOR EnLite instrument is intended for the quantitative determination of TREC (T-cell rece