Identity
- Trade Name
- DAB Substrate Kit EUDAMED
- Device Name
- DAB Substrate Kit EUDAMED
- Model / Reference
- 957D-X series EUDAMED957D-60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683102595 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
Similar devices
Also classified as Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry.
- Thermo Scientific — Richard-Allan Scientific LLC · Class I
- Thermo Scientific — Richard-Allan Scientific LLC · Class I
- Thermo Scientific — Richard-Allan Scientific LLC · Class I
- Thermo Scientific — Richard-Allan Scientific LLC · Class I
- p16/ Ki-67 dual stain cytology kit — Yaneng BIOscience (Shenzhen) Co., Ltd. · Class A
- Thermo Scientific — Richard-Allan Scientific LLC · Class I
- ONCORE Pro ISH HRP Detection — BIOCARE MEDICAL, LLC · Class I
- Thermo Scientific — Richard-Allan Scientific LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cell Marque Corporation
- EUDAMED SRN
- US-MF-000028332
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED aefbc683-9e80-4975-83aa-ef3e3347fa36 61 fields · synced Jun 18, 2026