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IDH1 R132H (MRQ-67) Rabbit Monoclonal Antibody
EUDAMEDFDA UDIClass C (EU MDR)
Ref 760-7173Ref 456R-35Model 456R-3X series
Identity
- Trade Name
- IDH1 R132H (MRQ-67) Rabbit Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Isocitrate dehydrogenase 1 (IDH1) IVD, antibody FDA UDI
- Device Name
- IDH1 R132H (MRQ-67) Rabbit Monoclonal Antibody EUDAMED
- Model / Reference
- 760-7173 EUDAMED456R-3X series EUDAMED456R-35 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04065268527306 EUDAMED00841683101703 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831760-71732T EUDAMED008416831456R-3ET EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Isocitrate dehydrogenase 1 (IDH1) 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
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
New Device
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
IDH1 R132H (MRQ-67) Rabbit Monoclonal Antibody by Cell Marque Corporation — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 008416831760-71732T | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
- EUDAMED SRN
- US-MF-000028332
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED cc831986-b56c-4617-ab99-b1d903c1d0fd 61 fields · synced Jul 20, 2026
- EUDAMED b70316c5-a3dc-4ec7-baef-438cf24ce090 61 fields · synced May 17, 2026
- FDA UDI 0fbd60a9-ca62-4f04-9c32-698f7a83e1e0 33 fields · synced May 30, 2026