Duns Number:342920388
Device Description: REA414 recognizes the human CD66c antigen, a glycosylphosphatidylinositol (GPI) linked pro REA414 recognizes the human CD66c antigen, a glycosylphosphatidylinositol (GPI) linked protein, which is also known as carcinoembryonic antigen-related cell adhesion molecule 6 (CEACAM6). Within the hematopoietic system, CD66c expression is limited to granulocytes and its precursors, where it serves homotypic and heterotypic adhesion, Ca2+ mediated signaling, and is markedly upregulated from intracellular stores after activation. It is also found in epithelia of various organs. CD66c overexpression is found in a wide variety of epithelial cancer types such as lung, breast, colorectal, and hepatocellular carcinomas.Additional information: Clone REA414 displays negligible binding to Fc receptors.
Catalog Number
-
Brand Name
CD66c-PE
Version/Model Number
170-081-052
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)
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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
2fcb992e-f19f-4b22-9afb-70a795151858
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 |