FDA UDI In Commercial Distribution 🇺🇸 United States

VENTANA PDL1 SP142 ASSAY

DI: 04015630967155 · Model: 50tests · Ventana Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
VENTANA PDL1 SP142 ASSAY
Primary DI
04015630967155
Version / Model
50tests
Catalog Number
07709374001
Company Name
Ventana Medical Systems, Inc.
Labeler DUNS
184042521
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-07-19
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
cec5a4d9-005f-4a86-bc99-7e23781cb33f

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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
PLS Immunohistochemistry assay, antibody, programmed death-ligand 1

GMDN Terms

Code Name
62046 Programmed death-ligand 1 (PD-L1) IVD, antibody

Identifiers

Type ID
Primary 04015630967155