ANTI-HUMAN PROGESTERONE RECEPTOR

Basic Information

• Brand Name: ANTI-HUMAN PROGESTERONE RECEPTOR
• Primary DI: 00810119676627
• Version / Model: AY711-YCD
• Catalog Number: AY711-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: 4c150f78-f247-4857-9500-2e3f6ce8f692

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
MXZ	Immunohistochemistry Assay, Antibody, Progesterone Receptor	Hematology	864.1860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57534	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 progesterone receptors in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810119676627	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at 2-8°C