FDA UDI In Commercial Distribution 🇺🇸 United States

Leuko-TIC VT plus

DI: 04061609000064 · Model: 004005-6100 · BIOANALYTIC GmbH, biomed. Analysentechnik
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100

Basic Information

Brand Name
Leuko-TIC VT plus
Primary DI
04061609000064
Version / Model
004005-6100
Company Name
BIOANALYTIC GmbH, biomed. Analysentechnik
Labeler DUNS
327536728
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2018-02-06
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
e4b973e7-4d8c-4072-8ddf-6faa50ac37da

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JCG Fluid, Diluting, Manual Cell

GMDN Terms

Code Name
55859 White blood cell count IVD, reagent

Identifiers

Type ID
Primary 04061609000064
Unit of Use 04061609000569