Identity
- Trade Name
- PolyQ Stain DAB Substrate Buffer EUDAMED
- Device Name
- Substrate Buffer EUDAMED
- Model / Reference
- CHR-103-050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255597806382 EUDAMED
- Basic UDI-DI
- 42555978DETECCHR103P6 EUDAMED
- Direct Marketing DI
- 04255597806382 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
PolyQ Stain DAB Substrate Buffer by biocyc Biotechnologie GmbH & Co. KG — Class A — CE/MDR — 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 | 42555978DETECCHR103P6 | Class A | Active |
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Manufacturer
- Manufacturer
- biocyc Biotechnologie GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000031533
Sources (1)
- EUDAMED 303c8538-7977-4e9c-a964-ad0bd2b1970d 61 fields · synced Oct 6, 2026