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anti-CMV Blend (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Primary Antibody
EUDAMEDFDA UDIClass C (EU MDR)
Ref 760-4703
Identity
- Trade Name
- anti-CMV Blend (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Primary Antibody EUDAMEDCMV (8B1.2,1G5.2&2D4.2) Mouse Monoclonal Antibody FDA UDI
- Generic Name
- Cytomegalovirus (CMV) antigen IVD, antibody FDA UDI
- Device Name
- anti-CMV Blend (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Primary Antibody EUDAMED
- Model / Reference
- 760-4703 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683101376 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831760-47032F 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
Yes
FDA UDI
anti-CMV Blend (8B1.2, 1G5.2 & 2D4.2) Mouse Monoclonal Primary 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 | 008416831760-47032F | 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 (2)
- EUDAMED fe58b6c1-2fd3-4893-b96e-fb8107ed1e17 61 fields · synced Jul 30, 2026
- FDA UDI bcc0ac5f-99a4-444f-98e3-8453efb2c800 34 fields · synced May 30, 2026