Duns Number:342920388
Device Description: REA675 recognizes the human CD19 antigen, a type I transmembrane glycoprotein of 95 kDa th REA675 recognizes the human CD19 antigen, a type I transmembrane glycoprotein of 95 kDa that belongs to the immunoglobulin superfamily. CD19 is expressed on B cells throughout most stages of B cell differentiation, though its expression is down-regulated during their terminal differentiation to plasma cells. Expression of CD19 is also found in the majority of B cell–derived malignancies. CD19 is further present on follicular dendritic cells. On B cells, CD19 associates with CD21, CD81, and CD225 (Leu-13) forming a signal transduction complex. Additional information: Clone REA675 displays negligible binding to Fc receptors.
Catalog Number
-
Brand Name
CD19-APC
Version/Model Number
170-081-067
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
9358c81f-925c-4691-b62e-0de7e734bd26
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 |