AccessGUDID - DEVICE: VICTOR2 D (06438147121373)

GUDID

Device Identifier (DI) Information

Brand Name: VICTOR2 D
Version or Model: 1420-021
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1420-021
Company Name: Wallac Oy

Primary DI Number: 06438147121373
Issuing Agency: GS1
Commercial Distribution End Date: April 22, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

Device Description: VICTOR2 D will primarly be used for measuring test kits supplied by Wallac especially for neonatal tests. Secondly VICTOR2 D can also be used for other measurements of TRF and prompt fluorescence. The user is a laboratory running screening on newborns or a general clinical chemistry lab running different hormones on blood samples.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56705	Fluorescent immunoassay analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHO	Fluorometer, For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a1aa2007-d47c-476d-8382-05b3122a395b
Public Version Date: August 01, 2024
Public Version Number: 3
DI Record Publish Date: March 19, 2019