FDA UDI In Commercial Distribution 🇺🇸 United States

HER2 3-in-1 Xenograft Control Slides

DI: 04015630971091 · Model: 05276101001 · Ventana Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HER2 3-in-1 Xenograft Control Slides
Primary DI
04015630971091
Version / Model
05276101001
Catalog Number
05276101001
Company Name
Ventana Medical Systems, Inc.
Labeler DUNS
184042521
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-01-29
Public Version
2
Public Version Date
2021-06-18
Public Version Status
Update
Public Device Record Key
27907a0d-13e9-4660-b61d-c369f0760ee9

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
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
KIR CELLS, ANIMAL AND HUMAN, CULTURED

GMDN Terms

Code Name
41906 Nucleic acid hybridization detection IVD, control

Identifiers

Type ID
Primary 04015630971091