Duns Number:342920388
Device Description: Clone REA209 recognizes CD42a, a 22 KDa transmembrane glycoprotein, which is also known as Clone REA209 recognizes CD42a, a 22 KDa transmembrane glycoprotein, which is also known as glycoprotein IX (GPIX). CD42a is a single-pass type I membrane protein with leucine rich motif containing a series of tandem repeats of a 24-amino acid sequence flanked by conserved disulfide loops, in its ligand binding domains. Expression of CD42a is found on platelets and megakaryocytes. CD42a, together with GPIb receptor complex and platelet glycoprotein V forms a complex which serves as the receptor for von Willebrand factor (VWF). The interaction of the GPIb-IX-V complex to VWF initiates initial platelet adhesion to vascular subendothelium after vascular injury, platelet activation, thrombosis, and hemostasis. Other known ligands for GPIb–IX–V include α-thrombin, clotting factors XI/XIIa, and high-molecular weight kininogen. Additional information: Clone REA209 displays negligible binding to Fc receptors.
Catalog Number
-
Brand Name
CD42a-FITC
Version/Model Number
170-081-030
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
84382489-b6e0-4b60-9baa-120570dc951b
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 |