AccessGUDID - DEVICE: VENTANA HER2 Dual ISH DNA Probe Cocktail (07613336158432)

GUDID

Device Identifier (DI) Information

Brand Name: VENTANA HER2 Dual ISH DNA Probe Cocktail
Version or Model: 08314365001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08314365001
Company Name: Ventana Medical Systems, Inc.

Primary DI Number: 07613336158432
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?
61199	Nucleic acid hybridization detection IVD, probe	A defined piece(s) of nucleic acid, typically tagged with a fluorescent marker, intended to be used for the detection of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, in order to identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion). It is typically used in nucleic acid hybridization detection techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NYQ	Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P190031	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: 877db5c3-c2a6-483b-8fbd-4af78b3f1e78
Public Version Date: April 19, 2021
Public Version Number: 1
DI Record Publish Date: April 09, 2021