Identity
- Trade Name
- Anti-TCRa/b-PE (Clone REA652) FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- REA652 recognizes the human alpha/beta T cell receptor (TCR). The T cell receptor is a heterodimer composed of two transmembrane glycoprotein chains, alpha and beta. In 95% of T cells the TCR consists of an alpha and beta chain, whereas in 5% of T cells it has gamma and delta chains. Alpha and beta 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. Additional information: Clone REA652 displays negligible binding to Fc receptors. FDA UDI
- Model / Reference
- 170-081-069 FDA UDI
- Description
- REA652 recognizes the human alpha/beta T cell receptor (TCR). The T cell receptor is a heterodimer composed of two transmembrane glycoprotein chains, alpha and beta. In 95% of T cells the TCR consists of an alpha and beta chain, whereas in 5% of T cells it has gamma and delta chains. Alpha and beta 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. Additional information: Clone REA652 displays negligible binding to Fc receptors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934133909 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 REA652) by Miltenyi Biotec B.V. & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Miltenyi Biotec B.V. & Co. KG
Sources (1)
- FDA UDI c29eff9b-2afd-4d69-9a91-16016875492d 35 fields · synced May 30, 2026