Identity
- Trade Name
- CD62L-VioGreen FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- 145/15 recognizes the human CD62L antigen, a 74 kDa glycoprotein and a member of the selectin family of cell surface molecules. CD62L is also known as L-selectin, LECAM-1, or LAM-1 and binds a series of glycoproteins including CD34, GlyCAM-1, and MAdCAM-1. CD62L is important for homing of naive lymphocytes via endothelial venules to peripheral lymph nodes and Peyer’s patches. The CD62L antigen also contributes to the recruitment of leukocytes from the blood to areas of inflammation. Most hematopoietic cells express CD62L, including many peripheral blood B cells, T cells, monocytes, granulocytes, and some myeloid cells from bone marrow, and thymocytes. CD62L is continuously endoproteolytically cleaved from the cell surface neutrophils and lymphocytes (shedding). Proteolysis is accelerated, for example, after antigenic activation of T cells. Always use fresh material for immunofluorescent staining of CD62L+ cells. For optimal results, the cells should not be older than 8–12 hours. Keep cells continuously cold. CD62L-expression may be rapidly lost due to shedding. FDA UDI
- Model / Reference
- 170-081-081 FDA UDI
- Description
- 145/15 recognizes the human CD62L antigen, a 74 kDa glycoprotein and a member of the selectin family of cell surface molecules. CD62L is also known as L-selectin, LECAM-1, or LAM-1 and binds a series of glycoproteins including CD34, GlyCAM-1, and MAdCAM-1. CD62L is important for homing of naive lymphocytes via endothelial venules to peripheral lymph nodes and Peyer’s patches. The CD62L antigen also contributes to the recruitment of leukocytes from the blood to areas of inflammation. Most hematopoietic cells express CD62L, including many peripheral blood B cells, T cells, monocytes, granulocytes, and some myeloid cells from bone marrow, and thymocytes. CD62L is continuously endoproteolytically cleaved from the cell surface neutrophils and lymphocytes (shedding). Proteolysis is accelerated, for example, after antigenic activation of T cells. Always use fresh material for immunofluorescent staining of CD62L+ cells. For optimal results, the cells should not be older than 8–12 hours. Keep cells continuously cold. CD62L-expression may be rapidly lost due to shedding. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049934133787 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
CD62L-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 cfe52037-6d93-4989-8abf-973eaec6d638 35 fields · synced May 30, 2026