FDA UDI In Commercial Distribution 🇺🇸 United States

VerséaTM Ophthalmics 4.3” Lateral Flow Reader

DI: 00860009215108 · Model: 100033000 · Axim Biotechnologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
VerséaTM Ophthalmics 4.3” Lateral Flow Reader
Primary DI
00860009215108
Version / Model
100033000
Catalog Number
900033000VE
Company Name
Axim Biotechnologies, Inc.
Labeler DUNS
079498248
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-10-03
Public Version
1
Public Version Date
2022-10-11
Public Version Status
New
Public Device Record Key
ecf89a39-2aad-449c-8408-8a00ac62bb2e

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

GMDN Terms

Code Name
42625 Photometric/spectroscopic immunoassay analyser IVD

Identifiers

Type ID
Package 00860009215115
Primary 00860009215108