Identity
- Trade Name
- CD14-APC FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- REA599 recognizes the human CD14 antigen. CD14 is part of the functional heteromeric LPS receptor complex comprised of at least CD14, TLR4, and MD-2. It up-regulates cell surface molecules, including adhesion molecules. CD14 is strongly expressed on most human monocytes and macrophages in peripheral blood, other bodily fluids, and in various tissues, such as lymph nodes and spleen. CD14 is weakly expressed on subpopulations of human neutrophils and myeloid dendritic cells. Additional information: Clone REA599 displays negligible binding to Fc receptors. FDA UDI
- Model / Reference
- 170-081-072 FDA UDI
- Description
- REA599 recognizes the human CD14 antigen. CD14 is part of the functional heteromeric LPS receptor complex comprised of at least CD14, TLR4, and MD-2. It up-regulates cell surface molecules, including adhesion molecules. CD14 is strongly expressed on most human monocytes and macrophages in peripheral blood, other bodily fluids, and in various tissues, such as lymph nodes and spleen. CD14 is weakly expressed on subpopulations of human neutrophils and myeloid dendritic cells. Additional information: Clone REA599 displays negligible binding to Fc receptors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934133879 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
Cd14-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 e946f658-6b4e-466a-8fc0-807bc6d82729 35 fields · synced Jun 8, 2026