Duns Number:342920388
Device Description: DB105 recognizes the CD44 antigen. CD44 is a marker for many types of cancer stem cells (C DB105 recognizes the CD44 antigen. CD44 is a marker for many types of cancer stem cells (CSC), including breast CSCs that possess higher tumorigenicity and metastatic potential, colorectal, pancreatic, and prostate CSCs. In addition, expression was observed in several cancers as well as on carcinoma cell lines. Here, CD44 plays a role in cancer cell migration and matrix adhesion in response to a cellular microenvironment, thus enhancing cellular aggregation and tumor cell growth. CD44 is also expressed on mesodermal cells, such as hematopoietic, fibroblastic, and glial cells.
Catalog Number
-
Brand Name
CD44-FITC
Version/Model Number
170-081-032
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)
-
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MVU
Product Code Name
Reagents, Specific, Analyte
Public Device Record Key
556af0e0-edd0-4b42-924f-7747c44688dc
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 |