Identity
- Trade Name
- CD3-FITC (Clone REA613) FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- REA613 recognizes the human CD3 antigen, a single-pass type I membrane protein, also known as Leu4. CD3 is present on mature human T cells, thymocytes, a subset of NK cells, and on Purkinje cells in cerebellum. It is associated with the T cell receptor (TCR) and is responsible for its signal transduction. The CD3 antigen is a complex of five invariable chains: gamma, delta, epsilon, zeta and eta. The epitope recognized by the antibody is located on the epsilon-chain of the CD3 complex. Additional information: Clone REA613 displays negligible binding to Fc receptors. FDA UDI
- Model / Reference
- 170-081-054 FDA UDI
- Description
- REA613 recognizes the human CD3 antigen, a single-pass type I membrane protein, also known as Leu4. CD3 is present on mature human T cells, thymocytes, a subset of NK cells, and on Purkinje cells in cerebellum. It is associated with the T cell receptor (TCR) and is responsible for its signal transduction. The CD3 antigen is a complex of five invariable chains: gamma, delta, epsilon, zeta and eta. The epitope recognized by the antibody is located on the epsilon-chain of the CD3 complex. Additional information: Clone REA613 displays negligible binding to Fc receptors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134050 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
CD3-FITC (Clone REA613) 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 40dbb767-3fc4-406e-8689-a7fc69c57631 35 fields · synced May 31, 2026