HER2 IQFISH pharmDx™

Basic Information

• Brand Name: HER2 IQFISH pharmDx™
• Primary DI: 05700572032465
• Version / Model: K5731
• Company Name: AGILENT TECHNOLOGIES SINGAPORE PTE LTD
• Labeler DUNS: 894671143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-15
• Public Version: 7
• Public Version Date: 2020-12-07
• Public Version Status: Update
• Public Device Record Key: 22d4b094-db5e-45cf-8253-3c4dbb5f0846

Device Description

HER2 IQFISH pharmDx™

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVD	System, Test, Her-2/Neu, Nucleic Acid Or Serum	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60255	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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700572032465	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20 Tests

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – -18 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight