Identity
- Trade Name
- CD33-APC FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- AC104.3E3 recognizes the human CD33 antigen, a 67 kDa glycoprotein belonging to the sialoadhesin superfamily. The CD33 antigen is highly expressed on human monocytes but weakly on granulocytes and some – but not all – myeloid dendritic cells. The CD33 antigen is also found on myeloid progenitor cells (CFU-GEMM, CFU GM, CFU-G, BFU-E) but is not expressed on lymphocytes, platelets, erythrocytes, or primitive hematopoietic stem cells. FDA UDI
- Model / Reference
- 170-081-024 FDA UDI
- Description
- AC104.3E3 recognizes the human CD33 antigen, a 67 kDa glycoprotein belonging to the sialoadhesin superfamily. The CD33 antigen is highly expressed on human monocytes but weakly on granulocytes and some – but not all – myeloid dendritic cells. The CD33 antigen is also found on myeloid progenitor cells (CFU-GEMM, CFU GM, CFU-G, BFU-E) but is not expressed on lymphocytes, platelets, erythrocytes, or primitive hematopoietic stem cells. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134357 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
Cd33-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 84cd83d7-c287-4dc0-a3ff-daa0be8a2e3a 35 fields · synced May 30, 2026