ANTI-ESTROGEN RECEPTOR-ALPHA

Basic Information

• Brand Name: ANTI-ESTROGEN RECEPTOR-ALPHA
• Primary DI: 00810119676580
• Version / Model: AY710-YCD
• Catalog Number: AY710-YCD
• Company Name: BIOGENEX LABORATORIES
• Labeler DUNS: 042697045
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-16
• Public Version: 1
• Public Version Date: 2023-05-24
• Public Version Status: New
• Public Device Record Key: 46797578-5c7b-4913-b0bf-38ce955c25ba

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
MVU	Reagents, Specific, Analyte	Pathology	864.4020	1
MYA	Immunohistochemistry Antibody Assay, Estrogen Receptor	Hematology	864.1860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54173	Estrogen (oestrogen) receptor IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of estrogen (oestrogen) receptors in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810119676580	GS1

Customer Contacts

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