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Anti-TCRa/b-PE (Clone BW242/412)

FDA UDI

Class I (US FDA UDI)

by Miltenyi Biotec B.V. & Co. KG

Identity

Trade Name
Anti-TCRa/b-PE (Clone BW242/412) FDA UDI
Generic Name
Assay development analyte-specific reagent IVD FDA UDI
Device Name
BW242/412 recognizes the human alpha/beta T cell receptor (TCR). The T cell receptor (TCR) is a heterodimer composed of two transmembrane glycoprotein chains, alpha and beta. Both chains are members of the Ig superfamily and consist of a constant and a polymorphic variable region. The variable region of the TCRalpha/beta is involved in recognition of antigenic peptides presented by the MHC complex of antigen-presenting cells. The Anti-TCRalpha/beta antibody, BW242/412, recognizes a common determinant of the TCRalpha/beta-CD3 complex. FDA UDI
Model / Reference
170-081-005 FDA UDI
Description
BW242/412 recognizes the human alpha/beta T cell receptor (TCR). The T cell receptor (TCR) is a heterodimer composed of two transmembrane glycoprotein chains, alpha and beta. Both chains are members of the Ig superfamily and consist of a constant and a polymorphic variable region. The variable region of the TCRalpha/beta is involved in recognition of antigenic peptides presented by the MHC complex of antigen-presenting cells. The Anti-TCRalpha/beta antibody, BW242/412, recognizes a common determinant of the TCRalpha/beta-CD3 complex. FDA UDI

Identifiers

Primary DI / UDI-DI
04049934134548 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-TCRa/b-PE (Clone BW242/412) 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 5d7950eb-105b-43f8-9f40-fb981cc262b3 35 fields · synced Jun 8, 2026