Duns Number:342920388
Device Description: Clone REA340 recognizes the human CD22 antigen, a single-pass type I membrane protein whic 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.
Catalog Number
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Brand Name
CD22-APC
Version/Model Number
170-081-043
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
2f7f1b62-5612-4068-aff6-7a48d5054619
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 |