AccessGUDID - DEVICE: HER2 CISH pharmDx™ Kit (05700572032960)

GUDID

Device Identifier (DI) Information

Brand Name: HER2 CISH pharmDx™ Kit
Version or Model: SK109
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dako Denmark A/S

Primary DI Number: 05700572032960
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305047466 *Terms of Use

Device Description: HER2 CISH pharmDx Kit

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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Her2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials 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, using a nucleic acid technique (NAT).

FDA Product Code

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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

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Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Store in the dark

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20 Tests

Device Record Status

Public Device Record Key: 23700536-ef99-466a-8e1c-73d88d501d4f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 15, 2014