HBME-1 (HBME-1) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- HBME-1 (HBME-1) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Hector Battifora mesothelial-1 (HBME-1) antigen IVD, antibody FDA UDI
- Device Name
- HBME-1 (HBME-1) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 283M-14 EUDAMEDFDA UDI283M-16 EUDAMEDFDA UDI283M-18 EUDAMEDFDA UDI283M-1X series EUDAMED283M-15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683132998 EUDAMEDFDA UDI00841683133018 EUDAMEDFDA UDI00841683133032 EUDAMEDFDA UDI00841683133001 FDA UDI
- Basic UDI-DI
- 008416831283M-1DG 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
No
Category: Hector Battifora mesothelial-1 (HBME-1) antigen IVD, antibody
HBME-1 (HBME-1) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 (7)
- FDA UDI 4c4c9d13-4d52-43c1-b5ac-42f15f58908f 33 fields · synced Aug 2, 2026
- FDA UDI d8e0f16b-c1c8-46b7-b029-baf53db0e664 33 fields · synced May 30, 2026
- FDA UDI 703b3e33-00c8-46f8-bd31-06f4f176d72b 33 fields · synced May 30, 2026
- FDA UDI 6d267ee9-4eb5-441b-bf32-95ae70644567 33 fields · synced May 30, 2026
- EUDAMED bb01f55b-b496-48da-a72c-84b2f9eeb7df 61 fields · synced Jul 24, 2026
- EUDAMED 02c934cf-92cc-4a7a-b3e6-24e1e53e5fc9 61 fields · synced Jul 25, 2026
- EUDAMED a184a3d1-2807-4eb6-a46c-43cb2b517cc6 61 fields · synced Aug 2, 2026