Identity
- Trade Name
- CD13-PE FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- REA263 recognizes the CD13 antigen, a 150–170 kDa type II transmembrane glycoprotein, which is also known as aminopeptidase N or gp150. CD13 is expressed on granulocytes, myeloid progenitors, endothelial cells, epithelial cells, and subset of granular lymphoid cells. It is also broadly expressed in other tissues such as kidney proximal tubules, intestine, and placenta. CD13 is an enzyme that is used as a biomarker to detect damage to the kidneys, and that may be used to help diagnose certain kidney disorders. It also serves as a receptor for one strain of human coronavirus that is an important cause of upper respiratory tract infections. Defects in CD13 appear to be a cause of various types of leukemia or lymphoma. Additional information: Clone REA263 displays negligible binding to Fc receptors. FDA UDI
- Model / Reference
- 170-081-019 FDA UDI
- Description
- REA263 recognizes the CD13 antigen, a 150–170 kDa type II transmembrane glycoprotein, which is also known as aminopeptidase N or gp150. CD13 is expressed on granulocytes, myeloid progenitors, endothelial cells, epithelial cells, and subset of granular lymphoid cells. It is also broadly expressed in other tissues such as kidney proximal tubules, intestine, and placenta. CD13 is an enzyme that is used as a biomarker to detect damage to the kidneys, and that may be used to help diagnose certain kidney disorders. It also serves as a receptor for one strain of human coronavirus that is an important cause of upper respiratory tract infections. Defects in CD13 appear to be a cause of various types of leukemia or lymphoma. Additional information: Clone REA263 displays negligible binding to Fc receptors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134401 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
Cd13-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 a0c2f072-99ff-478d-ab04-6f056b4e7f2b 35 fields · synced May 30, 2026