Mesothelial Cell (HBME-1) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Mesothelial Cell (HBME-1) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Hector Battifora mesothelial-1 (HBME-1) antigen IVD, antibody FDA UDI
- Device Name
- Mesothelial Cell (HBME-1) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 760-4445 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683144021 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831760-44452G EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Hector Battifora mesothelial-1 (HBME-1) antigen IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Hector Battifora mesothelial-1 (HBME-1) antigen IVD, antibody
Mesothelial Cell (HBME-1) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (2)
- FDA UDI e3dc2c34-7c85-47d8-99c3-1bd6274a3a2e 33 fields · synced Jun 18, 2026
- EUDAMED 3eaff24e-ebfe-4d6d-921c-c9540a04a4d4 61 fields · synced Jun 18, 2026