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Anti-TCRg/d-PE-Vio770

FDA UDI

Class I (US FDA UDI)

by Miltenyi Biotec B.V. & Co. KG

Identity

Trade Name
Anti-TCRg/d-PE-Vio770 FDA UDI
Generic Name
Assay development analyte-specific reagent IVD FDA UDI
Device Name
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. FDA UDI
Model / Reference
170-081-085 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
04049934133749 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Assay development analyte-specific reagent IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Assay development analyte-specific reagent IVD

Anti-TCRg/d-PE-Vio770 by Miltenyi Biotec B.V. & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assay development analyte-specific reagent IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Miltenyi Biotec B.V. & Co. KG

Sources (1)

  • FDA UDI 75e353a3-cb11-4ab0-a359-6d88b168673b 35 fields · synced Jun 8, 2026