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 Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory Fluorescent immunoassay analyser IVD, laboratory

• 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