Duns Number:342920388
Device Description: Clone REA423 recognizes the human CD16 antigen, a single-pass type I membrane protein whic Clone REA423 recognizes the human CD16 antigen, a single-pass type I membrane protein which is also known as low affinity immunoglobulin gamma Fc region receptor III (FcRIII). CD16 is a 50–80 kDa glycoprotein that is expressed in two different isoforms. The transmembrane form is found on human NK cells, macrophages, and mast cells, while the glycosylphosphatidylinositol (GPI)-linked form is present on neutrophils. The human CD16 antigen is a low-affinity receptor for aggregated IgG. The transmembrane form plays a role in signal transduction, NK cell activation, and antibody-dependent cellular cytotoxicity. Clone REA423 recognizes both the extracellular domain of the transmembrane form as well as the GPI-linked form of the human CD16 antigen. CD16 is expressed on the majority of rhesus monkey NK cells and on a subset of monocytes but not on granulocytes. Additional information: Clone REA423 displays negligible binding to Fc receptors.
Catalog Number
-
Brand Name
CD16-FITC
Version/Model Number
170-081-021
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"
-
For Single-Use
-
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
22dd48fc-fadb-4aa2-9826-4133730a5c34
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 |