Duns Number:342920388
Device Description: 97C5 recognizes human CD10, the human common acute lymphoblastic leukemia antigen (CALLA). 97C5 recognizes human CD10, the human common acute lymphoblastic leukemia antigen (CALLA). CD10 is a 100 kDa cell surface molecule identical to human membrane-associated neutral endopeptidase (NEP) and also known as neprilysin or enkephalinase. Human CD10 is expressed on a wide variety of normal and neoplastic cell types from different tissues including neural and hematopoietic cells. It is expressed on pre– and pro–B cells and is involved in B cell development and differentiation. The antigen is also present on mature neutrophils, T cell precursors, and some T cell leukemias/lymphomas. Furthermore, CD10 is expressed on neoplastic cells of several B lymphoid leukemias/lymphomas.
Catalog Number
-
Brand Name
CD10-APC
Version/Model Number
170-081-017
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
e3f24144-7abb-48a7-a172-7f108ffbf220
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 |