AccessGUDID - DEVICE: VENTANA CLDN18 (43-14A) RxDx Assay (07613336149201)

GUDID

Device Identifier (DI) Information

Brand Name: VENTANA CLDN18 (43-14A) RxDx Assay
Version or Model: 08287066001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08287066001
Company Name: Ventana Medical Systems, Inc.

Primary DI Number: 07613336149201
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?
63782	Claudin protein 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 a claudin protein in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QJZ	Extracorporeal system for long-term respiratory / cardiopulmonary failure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P230018	000

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: 4baf60a2-6a65-4553-97f4-2533ad6f8191
Public Version Date: December 19, 2024
Public Version Number: 1
DI Record Publish Date: December 11, 2024