FLEX Mono Rb A-Hu Estrogen Receptor a, Cl EP1, RTU (Dako Omnis)

Basic Information

• Brand Name: FLEX Mono Rb A-Hu Estrogen Receptor a, Cl EP1, RTU (Dako Omnis)
• Primary DI: 05700571108147
• Version / Model: GA084
• Company Name: AGILENT TECHNOLOGIES, INC.
• Labeler DUNS: 084963177
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-01
• Public Version: 7
• Public Version Date: 2021-09-20
• Public Version Status: Update
• Public Device Record Key: 055c2068-c8d5-4817-8203-a1ec404bc753

Device Description

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
MYA	IMMUNOHISTOCHEMISTRY ANTIBODY ASSAY, ESTROGEN RECEPTOR	Hematology	864.1860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57210	Estrogen (oestrogen)/progesterone receptor 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 estrogen (oestrogen) and/or progesterone receptors in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700571108147	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	12	Milliliter

Storage Conditions

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