Identity
- Trade Name
- CD21-VioBlue FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- HB5 recognizes CD21, a type I membrane glycoprotein. Expression of CD21 in humans is found on B cells, follicular dendritic cells, subsets of epithelial cells, and thymic T cells. The primary function attributed to CD21 has been to amplify the B cell receptor (BCR)-mediated signal transduction in response to antigen recognition. To enhance the BCR mediated activation, CD21 associates with CD19 and CD81 in a B cell–specific signal transduction complex, where interaction of BCR with CR2/CD19 amplifies the signals. In addition, CD21 serves as a receptor for split products of complement protein C3, the gp350/220 viral coat protein of the EBV and the immunoregulatory protein CD23. FDA UDI
- Model / Reference
- 170-081-022 FDA UDI
- Description
- HB5 recognizes CD21, a type I membrane glycoprotein. Expression of CD21 in humans is found on B cells, follicular dendritic cells, subsets of epithelial cells, and thymic T cells. The primary function attributed to CD21 has been to amplify the B cell receptor (BCR)-mediated signal transduction in response to antigen recognition. To enhance the BCR mediated activation, CD21 associates with CD19 and CD81 in a B cell–specific signal transduction complex, where interaction of BCR with CR2/CD19 amplifies the signals. In addition, CD21 serves as a receptor for split products of complement protein C3, the gp350/220 viral coat protein of the EBV and the immunoregulatory protein CD23. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134371 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
CD21-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 c070519b-4593-4d06-8814-e8803176d45f 35 fields · synced Jun 8, 2026