Identity
- Trade Name
- CD22-VioBlue FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- Clone REA340 recognizes the human CD22 antigen, a single-pass type I membrane protein which is also known as sialic acid-binding Ig-like lectin 2 (Siglec-2). In peripheral blood, cell surface expression of CD22 is found on mature B cells, but is lost during terminal differentiation to plasma cells. In bone marrow, surface expression of CD22 can be detected from the pre–B cell stage on. Cytoplasmic expression of CD22 can also be found in late pro–B cells and early–B cells. CD22 plays a strong role in cell interactions and B cell activation. It is a regulatory molecule that prevents the overactivation of the immune system and the development of autoimmune diseases. CD22 has emerged as an ideal target for monoclonal antibody based therapy of B cell malignancies including most lymphomas and many leukemias. Additional information: Clone REA340 displays negligible binding to Fc receptors. FDA UDI
- Model / Reference
- 170-081-041 FDA UDI
- Description
- Clone REA340 recognizes the human CD22 antigen, a single-pass type I membrane protein which is also known as sialic acid-binding Ig-like lectin 2 (Siglec-2). In peripheral blood, cell surface expression of CD22 is found on mature B cells, but is lost during terminal differentiation to plasma cells. In bone marrow, surface expression of CD22 can be detected from the pre–B cell stage on. Cytoplasmic expression of CD22 can also be found in late pro–B cells and early–B cells. CD22 plays a strong role in cell interactions and B cell activation. It is a regulatory molecule that prevents the overactivation of the immune system and the development of autoimmune diseases. CD22 has emerged as an ideal target for monoclonal antibody based therapy of B cell malignancies including most lymphomas and many leukemias. Additional information: Clone REA340 displays negligible binding to Fc receptors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134180 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
CD22-VioBlue 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 6eaa0535-4133-4fe0-b94c-45e024413a3d 35 fields · synced Jun 8, 2026