Identity
- Trade Name
- CD20-VioGreen FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- LT20 recognizes the CD20 antigen, a non-glycosylated transmembrane protein of 33–37 kDa that is expressed on B lineage cells from the pre-B cell stage to the B cell lymphoblast stage. The antigen is further expressed on most malignant B cells. CD20 is not found on early B cell progenitors or plasma cells. Oligomers of CD20 form a Ca2+ channel and might function in the regulation of local responses during B cell activation. FDA UDI
- Model / Reference
- 170-081-058 FDA UDI
- Description
- LT20 recognizes the CD20 antigen, a non-glycosylated transmembrane protein of 33–37 kDa that is expressed on B lineage cells from the pre-B cell stage to the B cell lymphoblast stage. The antigen is further expressed on most malignant B cells. CD20 is not found on early B cell progenitors or plasma cells. Oligomers of CD20 form a Ca2+ channel and might function in the regulation of local responses during B cell activation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934134012 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
CD20-VioGreen 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 3301fb09-3a16-44a8-a529-c2ca0ad7fefe 35 fields · synced Jun 8, 2026