Identity
- Trade Name
- CD27-APC FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- M-T271 recognizes CD27, a member of the tumor necrosis factor receptor family. CD27 is expressed at differing levels on memory B cells, a fraction of plasma cells, and on naive and memory T cells, but is not expressed on naive B cells or effector T cells. It is also expressed on NK cells. CD27 therefore represents a useful marker to distinguish certain T and B cell subsets from each other. FDA UDI
- Model / Reference
- 170-081-010 FDA UDI
- Description
- M-T271 recognizes CD27, a member of the tumor necrosis factor receptor family. CD27 is expressed at differing levels on memory B cells, a fraction of plasma cells, and on naive and memory T cells, but is not expressed on naive B cells or effector T cells. It is also expressed on NK cells. CD27 therefore represents a useful marker to distinguish certain T and B cell subsets from each other. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134494 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
Cd27-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 7a49e49b-9e34-44fa-8d7d-a272a6d54b42 35 fields · synced May 30, 2026