AccessGUDID - DEVICE: VENTANA FOLR1 Stain Intensity Reference Slide (07613336188019)

GUDID

Device Identifier (DI) Information

Brand Name: VENTANA FOLR1 Stain Intensity Reference Slide
Version or Model: 09382780001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 09382780001
Company Name: Ventana Medical Systems, Inc.

Primary DI Number: 07613336188019
Issuing Agency: GS1
Commercial Distribution End Date: February 09, 2024
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):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62801	Folate receptor alpha (FRa) 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 folate receptor alpha (FRa), in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QUL	Immunohistochemistry Assay, Antibody, FOLR1

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P220006	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: 27d8aece-b1a4-4bd5-a0c5-f9fbcaaf4cff
Public Version Date: November 21, 2024
Public Version Number: 2
DI Record Publish Date: December 01, 2022