Anti-TCRg/d-PE

Basic Information

• Brand Name: Anti-TCRg/d-PE
• Primary DI: 04049934133886
• Version / Model: 170-081-071
• 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: 39531799-0a86-49bc-9372-8b066a6174e9

Device Description

11F2 recognizes the human gamma/delta T cell receptor (TCR). The T cell receptor is a heterodimeric glycoprotein associated with the CD3 antigen. The TCR consists of a alpha and a beta chain (TCRa/b) or a gamma and a delta chain (TCRg/d). Clone 11F2 reacts with a framework epitope of the gamma/delta T cell–receptor. The gamma and delta TCR chains are composed of constant and variable regions, each encoded by distinct gene segments. The gamma chain forms either disulfide-linked or non-disulfide-linked heterodimers with the delta-subunit. The gamma/delta T cell–receptor is present on a subset of T lymphocytes in peripheral blood, intestinal epithelium, lymph node, thymus, and spleen. TCR gamma/delta is involved in the recognition of certain bacterial, self-CD1 molecule, and tumor antigens bound to MHC class I. Gamma/delta T cells are mainly CD4 negative and CD8 negative. T cells expressing the gamma/delta TCR have been shown to play a role in oral tolerance, innate immune response for some tumor cells, and autoimmune disease. Antigen presentation by gamma/delta T cells has been reported.

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	04049934133886	GS1

Customer Contacts

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

Storage Conditions

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