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D2-40 Lymphatic Endothelial Marker Monoclonal Antibody
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 916601
Identity
- Trade Name
- D2-40 Lymphatic Endothelial Marker Monoclonal Antibody FDA UDI
- Generic Name
- D2-40 antigen IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- D2-40 Lymphatic Endothelial Marker Monoclonal Antibody EUDAMEDURL: https://www.biolegend.com/en-us/products/d2-40-lymphatic-endothelial-marker-monoclonal-antibody-10930 FDA UDI
- Model / Reference
- 916601 EUDAMEDFDA UDI
- Description
- URL: https://www.biolegend.com/en-us/products/d2-40-lymphatic-endothelial-marker-monoclonal-antibody-10930 FDA UDI
Identifiers
- Catalog Number
- 916601 FDA UDI
- Primary DI / UDI-DI
- 00810034700322 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810034700322 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- D2-40 antigen IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 100 Microliter FDA UDI
D2-40 Lymphatic Endothelial Marker Monoclonal Antibody by Biolegend, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00810034700322 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- BioLegend Inc
- EUDAMED SRN
- US-MF-000013824
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED ba8bd921-ab5c-4ae8-a34a-e6530482c331 61 fields · synced Jun 19, 2026
- FDA UDI 0909f4ca-5c4f-47c6-823e-6a1080c31b72 37 fields · synced May 30, 2026