Identity
- Trade Name
- CD16-APC FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- Clone REA423 recognizes the human CD16 antigen, a single-pass type I membrane protein which is also known as low affinity immunoglobulin gamma Fc region receptor III (FcRIII). CD16 is a 50–80 kDa glycoprotein that is expressed in two different isoforms. The transmembrane form is found on human NK cells, macrophages, and mast cells, while the glycosylphosphatidylinositol (GPI)-linked form is present on neutrophils. The human CD16 antigen is a low-affinity receptor for aggregated IgG. The transmembrane form plays a role in signal transduction, NK cell activation, and antibody-dependent cellular cytotoxicity. Clone REA423 recognizes both the extracellular domain of the transmembrane form as well as the GPI-linked form of the human CD16 antigen. CD16 is expressed on the majority of rhesus monkey NK cells and on a subset of monocytes but not on granulocytes. Additional information: Clone REA423 displays negligible binding to Fc receptors. FDA UDI
- Model / Reference
- 170-081-045 FDA UDI
- Description
- Clone REA423 recognizes the human CD16 antigen, a single-pass type I membrane protein which is also known as low affinity immunoglobulin gamma Fc region receptor III (FcRIII). CD16 is a 50–80 kDa glycoprotein that is expressed in two different isoforms. The transmembrane form is found on human NK cells, macrophages, and mast cells, while the glycosylphosphatidylinositol (GPI)-linked form is present on neutrophils. The human CD16 antigen is a low-affinity receptor for aggregated IgG. The transmembrane form plays a role in signal transduction, NK cell activation, and antibody-dependent cellular cytotoxicity. Clone REA423 recognizes both the extracellular domain of the transmembrane form as well as the GPI-linked form of the human CD16 antigen. CD16 is expressed on the majority of rhesus monkey NK cells and on a subset of monocytes but not on granulocytes. Additional information: Clone REA423 displays negligible binding to Fc receptors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134142 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
Cd16-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 9ce79b94-d5e0-4c0b-bb84-d26acadcd712 35 fields · synced May 29, 2026