FDA UDI In Commercial Distribution 🇺🇸 United States

PATHWAY Anti-c-KIT (9.7) Primary Antibody

DI: 04015630971916 · Model: 50 tests · Ventana Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PATHWAY Anti-c-KIT (9.7) Primary Antibody
Primary DI
04015630971916
Version / Model
50 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
36758834-f0dd-470e-b544-08c43ddbac5f

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
No
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
NKF Immunohistochemistry antibody assay, c-kit

GMDN Terms

Code Name
57034 CD117 (c-kit) cell marker IVD, antibody

Identifiers

Type ID
Primary 04015630971916