Duns Number:342920388
Device Description: REA780 recognizes the human CD20 antigen, a non-glycosylated transmembrane protein of 33–3 REA780 recognizes the human CD20 antigen, a non-glycosylated transmembrane protein of 33–37 kDa that is expressed on B lineage cells from the pre–B cell stage to the B cell lymphoblast stage. The antigen is further expressed on most malignant B cells. CD20 is not found on early B cell progenitors or plasma cells. Oligomers of CD20 form a Ca2+ channel and might function in the regulation of local responses during B cell activation.Additional information: Clone REA780 displays negligible binding to Fc receptors.
Catalog Number
-
Brand Name
CD20-PE-Vio770
Version/Model Number
170-081-074
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
e8f733c4-e6fe-44fe-b0e1-b6b6179151b9
Public Version Date
April 05, 2021
Public Version Number
1
DI Record Publish Date
March 26, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 88 |