FDA UDI In Commercial Distribution 🇺🇸 United States

VICTOR2 D

DI: 06438147116126 · Model: 1420-020 · Wallac Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
VICTOR2 D
Primary DI
06438147116126
Version / Model
1420-020
Catalog Number
1420-020
Company Name
Wallac Oy
Labeler DUNS
540156544
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-03-19
Public Version
2
Public Version Date
2023-06-14
Public Version Status
Update
Public Device Record Key
d0812ce8-c9a4-4d7f-babf-11e6612d6eed

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

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KHO Fluorometer, For Clinical Use

GMDN Terms

Code Name
56705 Fluorescent immunoassay analyser IVD, laboratory

Identifiers

Type ID
Primary 06438147116126