EGFR pharmDx™ for Autostainer

Basic Information

• Brand Name: EGFR pharmDx™ for Autostainer
• Primary DI: 05700571103982
• Version / Model: K1494
• Company Name: AGILENT TECHNOLOGIES, INC.
• Labeler DUNS: 084963177
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-15
• Public Version: 7
• Public Version Date: 2023-03-28
• Public Version Status: Update
• Public Device Record Key: 2c20064d-8dd6-41c1-a670-8c8707932acc
• Distribution End Date: 2023-01-31

Device Description

EGFR pharmDx for Autostainer

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
NQF	Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor	Hematology	864.1860	3

GMDN Terms

Code	Name	Definition	Implantable	Status
57183	Epidermal growth factor receptor (EGFR) IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of epidermal growth factor receptor (EGFR) in a clinical specimen, using an enzyme immunohistochemistry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700571103982	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			50 Tests

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius