FDA UDI In Commercial Distribution 🇺🇸 United States

ultraView Universal DAB Detection Kit

DI: 04015630972173 · Model: 250 tests · Ventana Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ultraView Universal DAB Detection Kit
Primary DI
04015630972173
Version / Model
250 tests
Company Name
Ventana Medical Systems, Inc.
Labeler DUNS
184042521
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2014-09-11
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
c75b4e97-887e-48d6-bfd0-104fd340fef5

Device Characteristics

Single Use
No
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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NJT IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

GMDN Terms

Code Name
57771 Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry

Identifiers

Type ID
Primary 04015630972173