CD22-VioBlue

Basic Information

• Brand Name: CD22-VioBlue
• Primary DI: 04049934134180
• Version / Model: 170-081-041
• 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: 6eaa0535-4133-4fe0-b94c-45e024413a3d

Device Description

Clone REA340 recognizes the human CD22 antigen, a single-pass type I membrane protein which is also known as sialic acid-binding Ig-like lectin 2 (Siglec-2). In peripheral blood, cell surface expression of CD22 is found on mature B cells, but is lost during terminal differentiation to plasma cells. In bone marrow, surface expression of CD22 can be detected from the pre–B cell stage on. Cytoplasmic expression of CD22 can also be found in late pro–B cells and early–B cells. CD22 plays a strong role in cell interactions and B cell activation. It is a regulatory molecule that prevents the overactivation of the immune system and the development of autoimmune diseases. CD22 has emerged as an ideal target for monoclonal antibody based therapy of B cell malignancies including most lymphomas and many leukemias. Additional information: Clone REA340 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	04049934134180	GS1

Customer Contacts

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

Storage Conditions

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