Identity
- Trade Name
- CD45-VioBlue (Clone REA747) FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- REA747 recognizes the human CD45 antigen, a member of the protein tyrosine phosphatase (PTP) family, also known as the leukocyte common antigen (LCA). The CD45 molecule a type I transmembrane protein which is required for T and B cell activation and involved in cell growth, differentiation, mitotic cycle, and oncogenic transformation. CD45 is expressed in different isoforms (CD45RA, CD45RB, CD45RC, CD45RAB, CD45RAC, CD45RBC, CD45RO, CD45R (ABC)) depending on the differentiation status of the cell. The CD45 antibody recognizes a common epitope of all CD45 isoforms. Additional information: Clone REA747 displays negligible binding to Fc receptors. FDA UDI
- Model / Reference
- 170-081-077 FDA UDI
- Description
- REA747 recognizes the human CD45 antigen, a member of the protein tyrosine phosphatase (PTP) family, also known as the leukocyte common antigen (LCA). The CD45 molecule a type I transmembrane protein which is required for T and B cell activation and involved in cell growth, differentiation, mitotic cycle, and oncogenic transformation. CD45 is expressed in different isoforms (CD45RA, CD45RB, CD45RC, CD45RAB, CD45RAC, CD45RBC, CD45RO, CD45R (ABC)) depending on the differentiation status of the cell. The CD45 antibody recognizes a common epitope of all CD45 isoforms. Additional information: Clone REA747 displays negligible binding to Fc receptors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934133824 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
CD45-VioBlue (Clone REA747) 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 c58a5e58-19fb-4ff2-9025-e2d4bb85bdf0 35 fields · synced May 31, 2026