FLEX Mono Mo A-Hu CDX2 Cl DAK-CDX2 RTU

Basic Information

• Brand Name: FLEX Mono Mo A-Hu CDX2 Cl DAK-CDX2 RTU
• Primary DI: 05700571101407
• Version / Model: IS080
• Company Name: AGILENT TECHNOLOGIES, INC.
• Labeler DUNS: 084963177
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-17
• Public Version: 3
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: bfaa6745-6aae-43df-b95f-6a3d9378f378
• Distribution End Date: 2023-07-31

Device Description

FLEX Monoclonal Mouse Anti-Human CDX2 Clone DAK-CDX2 Ready-to-Use (Dako Autostainer/ Autostainer Plus)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
NJT	IMMUNOHISTOCHEMISTRY REAGENTS AND KITS	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57333	Homeobox protein CDX-2 IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of homeobox protein CDX-2, also referred to as caudal-type homeobox protein 2, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700571101407	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20-30 Tests

Storage Conditions

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