AccessGUDID - DEVICE: INFORM HER2 Dual ISH DNA Probe Cocktail (04015630970155)

GUDID

Device Identifier (DI) Information

Brand Name: INFORM HER2 Dual ISH DNA Probe Cocktail
Version or Model: 50 tests
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ventana Medical Systems, Inc.

Primary DI Number: 04015630970155
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?
60257	HER2/neu/erbB2 mRNA expression IVD, probe	A defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used for the qualitative and/or quantitative detection of mRNA expression of the HER2/neu/erbB2 (v-erb-B2 avian erythroblastic leukaemia viral oncogene homolog 2) gene in a tumour tissue specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NYQ	Chromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer

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: c64879d5-c6db-4ad3-b630-682fdbb804e7
Public Version Date: February 06, 2025
Public Version Number: 3
DI Record Publish Date: September 19, 2014