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Ki-67 (SP6) Rabbit Monoclonal Antibody
EUDAMEDFDA UDIClass C (EU MDR)
Ref 275R-17Model 275R-1X series
Identity
- Trade Name
- Ki-67 (SP6) Rabbit Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Ki67 antigen IVD, antibody FDA UDI
- Device Name
- Ki-67 (SP6) Rabbit Monoclonal Antibody EUDAMED
- Model / Reference
- 275R-1X series EUDAMED275R-17 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683132325 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831275R-1EC EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Ki67 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
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
Ki-67 (SP6) Rabbit Monoclonal Antibody by Cell Marque Corporation — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 008416831275R-1EC | 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 81c2c17e-d2ca-4ff2-bf2c-fd8682654165 61 fields · synced Jul 22, 2026
- FDA UDI 52a5616d-3119-40ea-8d5a-ffee08cc6d00 33 fields · synced May 30, 2026