Identity
- Trade Name
- CD42a-FITC FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 170-081-030 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134296 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Assay development analyte-specific reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assay development analyte-specific reagent IVD
CD42a-FITC by Miltenyi Biotec B.V. & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Miltenyi Biotec B.V. & Co. KG
Sources (1)
- FDA UDI 84382489-b6e0-4b60-9baa-120570dc951b 35 fields · synced Jun 8, 2026