AccessGUDID - DEVICE: VIRTUOSO System for IHC (04015630985043)

GUDID

Device Identifier (DI) Information

Brand Name: VIRTUOSO System for IHC
Version or Model: v5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06324444001
Company Name: VENTANA MEDICAL SYSTEMS, INC.

Primary DI Number: 04015630985043
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078501720 *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):	No
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?
58721	Histology/cytology/microbiology image-analysis interpretive software IVD	An interpretive software program with image analysis algorithms [e.g., artificial intelligence (AI)-based] intended to be used in a digital pathology or microbiology laboratory to assist in the analysis of clinical specimens (e.g., biopsy, blood smear, urine) and/or microbial cultures for the quantitative/qualitative detection of cell markers (e.g., hormone receptors), changes in tissue architecture and/or cell morphological/physiological characteristics [e.g., nucleus size, cytoplasmic granularity, rate of cell division], and/or infectious microorganisms associated with a disease (e.g., breast cancer, malaria, UTI). Results are also interpreted by a clinician to guide patient management.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQN	Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 77a41492-83c0-4262-80fa-6f8dfb4e6cfd
Public Version Date: April 15, 2022
Public Version Number: 7
DI Record Publish Date: September 24, 2016