DEVICE: CD21-VioBlue (04049934134371)
Device Identifier (DI) Information
CD21-VioBlue
170-081-022
In Commercial Distribution
Miltenyi Biotec B.V. & Co. KG
170-081-022
In Commercial Distribution
Miltenyi Biotec B.V. & Co. KG
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
64705 | Assay development analyte-specific reagent IVD |
An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MVU | Reagents, Specific, Analyte |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: 2 - 8 °C Protected from light. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c070519b-4593-4d06-8814-e8803176d45f
April 05, 2021
1
March 26, 2021
April 05, 2021
1
March 26, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-367-6227
technicalsupportUS@miltenyi.com
technicalsupportUS@miltenyi.com