CD8-APC-Vio770 (Clone REA734)

Basic Information

• Brand Name: CD8-APC-Vio770 (Clone REA734)
• Primary DI: 04049934133848
• Version / Model: 170-081-075
• 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: 11d5736f-0562-4a1d-9b84-f95af077b3e2

Device Description

REA734 recognizes the human CD8 antigen, a cell-surface glycoprotein also known as Leu-2 or CD8a. CD8 is strongly expressed on human cytotoxic T cells and thymocytes as well as on a subset of NK cells. The CD8 antigen is a disulfide-linked dimer that exists either as a CD8a homodimer or as a CD8alpha/beta heterodimer. CD8 acts as a co-receptor for the T cell receptor and binds to the MHC class I molecules. CD8 is involved in T cell development and activation of mature T cells. The CD8 antibody recognizes the alpha-subunit of the antigen. Additional information: Clone REA734 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	04049934133848	GS1

Customer Contacts

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

Storage Conditions

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