Identity
- Trade Name
- CD8-APC-Vio770 (Clone REA734) FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- REA734 recognizes the human CD8 antigen, a cell-surface glycoprotein also known as Leu-2 or CD8a. CD8 is strongly expressed on human cytotoxic T cells and thymocytes as well as on a subset of NK cells. The CD8 antigen is a disulfide-linked dimer that exists either as a CD8a homodimer or as a CD8alpha/beta heterodimer. CD8 acts as a co-receptor for the T cell receptor and binds to the MHC class I molecules. CD8 is involved in T cell development and activation of mature T cells. The CD8 antibody recognizes the alpha-subunit of the antigen. Additional information: Clone REA734 displays negligible binding to Fc receptors. FDA UDI
- Model / Reference
- 170-081-075 FDA UDI
- Description
- REA734 recognizes the human CD8 antigen, a cell-surface glycoprotein also known as Leu-2 or CD8a. CD8 is strongly expressed on human cytotoxic T cells and thymocytes as well as on a subset of NK cells. The CD8 antigen is a disulfide-linked dimer that exists either as a CD8a homodimer or as a CD8alpha/beta heterodimer. CD8 acts as a co-receptor for the T cell receptor and binds to the MHC class I molecules. CD8 is involved in T cell development and activation of mature T cells. The CD8 antibody recognizes the alpha-subunit of the antigen. Additional information: Clone REA734 displays negligible binding to Fc receptors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934133848 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
CD8-APC-Vio770 (Clone REA734) 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 11d5736f-0562-4a1d-9b84-f95af077b3e2 35 fields · synced May 31, 2026