Identity
- Trade Name
- CD42b-APC FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 170-081-031 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134289 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
CD42b-APC 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 96ae00d3-5166-4ad6-9cbd-fb740bc137fb 35 fields · synced May 30, 2026