Identity
- Trade Name
- CD10-APC FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- 97C5 recognizes human CD10, the human common acute lymphoblastic leukemia antigen (CALLA). CD10 is a 100 kDa cell surface molecule identical to human membrane-associated neutral endopeptidase (NEP) and also known as neprilysin or enkephalinase. Human CD10 is expressed on a wide variety of normal and neoplastic cell types from different tissues including neural and hematopoietic cells. It is expressed on pre– and pro–B cells and is involved in B cell development and differentiation. The antigen is also present on mature neutrophils, T cell precursors, and some T cell leukemias/lymphomas. Furthermore, CD10 is expressed on neoplastic cells of several B lymphoid leukemias/lymphomas. FDA UDI
- Model / Reference
- 170-081-017 FDA UDI
- Description
- 97C5 recognizes human CD10, the human common acute lymphoblastic leukemia antigen (CALLA). CD10 is a 100 kDa cell surface molecule identical to human membrane-associated neutral endopeptidase (NEP) and also known as neprilysin or enkephalinase. Human CD10 is expressed on a wide variety of normal and neoplastic cell types from different tissues including neural and hematopoietic cells. It is expressed on pre– and pro–B cells and is involved in B cell development and differentiation. The antigen is also present on mature neutrophils, T cell precursors, and some T cell leukemias/lymphomas. Furthermore, CD10 is expressed on neoplastic cells of several B lymphoid leukemias/lymphomas. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134425 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
Cd10-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 e3f24144-7abb-48a7-a172-7f108ffbf220 35 fields · synced May 30, 2026