CD13-PE

Basic Information

• Brand Name: CD13-PE
• Primary DI: 04049934134401
• Version / Model: 170-081-019
• Company Name: Miltenyi Biotec B.V. & Co. KG
• Labeler DUNS: 342920388
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-26
• Public Version: 1
• Public Version Date: 2021-04-05
• Public Version Status: New
• Public Device Record Key: a0c2f072-99ff-478d-ab04-6f056b4e7f2b

Device Description

REA263 recognizes the CD13 antigen, a 150–170 kDa type II transmembrane glycoprotein, which is also known as aminopeptidase N or gp150. CD13 is expressed on granulocytes, myeloid progenitors, endothelial cells, epithelial cells, and subset of granular lymphoid cells. It is also broadly expressed in other tissues such as kidney proximal tubules, intestine, and placenta. CD13 is an enzyme that is used as a biomarker to detect damage to the kidneys, and that may be used to help diagnose certain kidney disorders. It also serves as a receptor for one strain of human coronavirus that is an important cause of upper respiratory tract infections. Defects in CD13 appear to be a cause of various types of leukemia or lymphoma. Additional information: Clone REA263 displays negligible binding to Fc receptors.

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
64705	Assay development analyte-specific reagent IVD	An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049934134401	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 2 - 8 °C Protected from light.