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Monoclonal Mouse anti-human CD8/FITC, Clone SK1
EUDAMEDClass C (EU MDR)
Ref 8931023CEModel 50T,100T
Identity
- Device Name
- Monoclonal Mouse anti-human CD8/FITC, Clone SK1 EUDAMED
- Model / Reference
- 50T,100T EUDAMED8931023CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974501890795 EUDAMED
- Basic UDI-DI
- 69745018900C001001VF EUDAMED
- EMDN Code
- W0103080105 ANTIBODIES FOR SUBTYPING OF LEUKEMIA (EXCEPT B-&T-CELL TYPING) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Monoclonal Mouse anti-human CD8/FITC, Clone SK1 by Agilent Biosciences (Hangzhou) Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69745018900C001001VF | Class C | Active |
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Manufacturer
- Manufacturer
- Agilent Biosciences (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013066
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (1)
- EUDAMED d2998b7a-cff3-4b9f-856d-0bb023f0457b 61 fields · synced Jun 18, 2026