Identity
- Trade Name
- CD66c-PE FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- REA414 recognizes the human CD66c antigen, a glycosylphosphatidylinositol (GPI) linked protein, which is also known as carcinoembryonic antigen-related cell adhesion molecule 6 (CEACAM6). Within the hematopoietic system, CD66c expression is limited to granulocytes and its precursors, where it serves homotypic and heterotypic adhesion, Ca2+ mediated signaling, and is markedly upregulated from intracellular stores after activation. It is also found in epithelia of various organs. CD66c overexpression is found in a wide variety of epithelial cancer types such as lung, breast, colorectal, and hepatocellular carcinomas. Additional information: Clone REA414 displays negligible binding to Fc receptors. FDA UDI
- Model / Reference
- 170-081-052 FDA UDI
- Description
- REA414 recognizes the human CD66c antigen, a glycosylphosphatidylinositol (GPI) linked protein, which is also known as carcinoembryonic antigen-related cell adhesion molecule 6 (CEACAM6). Within the hematopoietic system, CD66c expression is limited to granulocytes and its precursors, where it serves homotypic and heterotypic adhesion, Ca2+ mediated signaling, and is markedly upregulated from intracellular stores after activation. It is also found in epithelia of various organs. CD66c overexpression is found in a wide variety of epithelial cancer types such as lung, breast, colorectal, and hepatocellular carcinomas. Additional information: Clone REA414 displays negligible binding to Fc receptors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134074 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
CD66c-PE 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 2fcb992e-f19f-4b22-9afb-70a795151858 35 fields · synced Jun 1, 2026