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CMV (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Antibody
EUDAMEDFDA UDIClass C (EU MDR)
Ref 213M-25Model 213M-2X seriesRef 213M-28Ref 213M-27
Identity
- Trade Name
- CMV (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Cytomegalovirus (CMV) antigen IVD, antibody FDA UDI
- Device Name
- CMV (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 213M-2X series EUDAMED213M-25 EUDAMED213M-28 EUDAMEDFDA UDI213M-27 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683127017 EUDAMED00841683127109 EUDAMEDFDA UDI00841683127079 EUDAMED
- Basic UDI-DI
- 008416831213M-2B5 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Cytomegalovirus (CMV) 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
- Not 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
CMV (8B1.2, 1G5.2 & 2D4.2) Mouse 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 | 008416831213M-2B5 | 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 (4)
- EUDAMED 3c17955f-ba82-41eb-993c-cb44f42ccc16 61 fields · synced Oct 1, 2026
- EUDAMED d65563dc-7ede-4411-a543-4dceecfa2e7e 61 fields · synced May 16, 2026
- EUDAMED 8f3ea696-6baa-4bae-975f-53bb867bceb1 61 fields · synced May 17, 2026
- FDA UDI 52343426-cdf4-41ec-ab93-842909de6a4c 34 fields · synced May 30, 2026