AccessGUDID - DEVICE: Anti-TCRg/d-PE (04049934133886)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-TCRg/d-PE
Version or Model: 170-081-071
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Miltenyi Biotec B.V. & Co. KG

Primary DI Number: 04049934133886
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342920388 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	Reagents, Specific, Analyte

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: 2 - 8 °C Protected from light.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 39531799-0a86-49bc-9372-8b066a6174e9
Public Version Date: April 05, 2021
Public Version Number: 1
DI Record Publish Date: March 26, 2021