FLEX Mono Mo A-Hu CD31, Endothelial Cell Cl JC70A RTU

Basic Information

• Brand Name: FLEX Mono Mo A-Hu CD31, Endothelial Cell Cl JC70A RTU
• Primary DI: 05700572028987
• Version / Model: IS610
• 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: 2020-09-17
• Public Version: 2
• Public Version Date: 2020-12-07
• Public Version Status: Update
• Public Device Record Key: 57a2de9a-0019-449d-9206-49ab9d2b5c55

Device Description

FLEX Monoclonal Mouse Anti-Human CD31, Endothelial Cell Clone JC70A 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
56970	CD31 endothelial cell marker 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 CD31 endothelial cell marker in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700572028987	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