AccessGUDID - DEVICE: VENTANA PD-L1 (SP263) Assay (04015630972784)

GUDID

Device Identifier (DI) Information

Brand Name: VENTANA PD-L1 (SP263) Assay
Version or Model: 50 test
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07208162001
Company Name: Ventana Medical Systems, Inc.

Primary DI Number: 04015630972784
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184042521 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62046	Programmed death-ligand 1 (PD-L1) IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of programmed death-ligand 1 (PD-L1), also known as CD274, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PLS	Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160046	000
P160046	010

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd70dc67-19c7-4989-a5b8-1606a046d44a
Public Version Date: November 10, 2021
Public Version Number: 5
DI Record Publish Date: September 26, 2017