Duns Number:342920388
Device Description: REA599 recognizes the human CD14 antigen. CD14 is part of the functional heteromeric LPS r REA599 recognizes the human CD14 antigen. CD14 is part of the functional heteromeric LPS receptor complex comprised of at least CD14, TLR4, and MD-2. It up-regulates cell surface molecules, including adhesion molecules. CD14 is strongly expressed on most human monocytes and macrophages in peripheral blood, other bodily fluids, and in various tissues, such as lymph nodes and spleen. CD14 is weakly expressed on subpopulations of human neutrophils and myeloid dendritic cells. Additional information: Clone REA599 displays negligible binding to Fc receptors.
Catalog Number
-
Brand Name
CD14-APC
Version/Model Number
170-081-072
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
e946f658-6b4e-466a-8fc0-807bc6d82729
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 |