Duns Number:342920388
Device Description: REA185 recognizes human CD42b, a 145 kDa, single-pass type I membrane protein. Expression REA185 recognizes human CD42b, a 145 kDa, single-pass type I membrane protein. Expression of CD42b is found on platelets and megakaryocytes. CD42b, the alpha chain, together with the beta chain (CD42c), forms the heterodimer, glycoprotein Ib (GP Ib). The GP Ib receptor complex further includes association of the alpha and beta subunits with platelet glycoprotein IX and glycoprotein V and this complex serves as the receptor for von Willebrand factor (VWF). The interaction of the GP Ib-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 REA185 displays negligible binding to Fc receptors.
Catalog Number
-
Brand Name
CD42b-APC
Version/Model Number
170-081-031
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
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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
96ae00d3-5166-4ad6-9cbd-fb740bc137fb
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
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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 |