Identity
- Trade Name
- DAB Substrate Kit EUDAMED
- Device Name
- DAB Substrate Kit EUDAMED
- Model / Reference
- 957D-X series EUDAMED957D-40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683125648 EUDAMED
- Basic UDI-DI
- 008416831957DV3 EUDAMED
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
DAB Substrate Kit by Cell Marque Corporation — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 008416831957DV3 | Class A | Active |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
- EUDAMED SRN
- US-MF-000028332
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED ef907019-e9c3-4ab5-95c7-1b94677b8d4c 61 fields · synced Jun 18, 2026