FLEX Poly Rb A-Hu Kappa LC RTU (Link)

Basic Information

• Brand Name: FLEX Poly Rb A-Hu Kappa LC RTU (Link)
• Primary DI: 05700572029472
• Version / Model: IR506
• 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: 1244cae6-0c1d-44fc-b8bc-76265fc90af0

Device Description

FLEX Polyclonal Rabbit Anti-Human Kappa Light Chains Ready-to-Use (Link)

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
57325	Kappa/lambda light chain immunoglobulin 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 kappa and/or lambda light chain immunoglobulins in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700572029472	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			40-60 Tests

Storage Conditions

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