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PolyQ Stain DAB, 2 components

EUDAMED

Class A (EU MDR)

Ref CHR-101-100

by biocyc Biotechnologie GmbH & Co. KG

Identity

Trade Name
PolyQ Stain DAB, 2 components EUDAMED
Device Name
detection systems EUDAMED
Model / Reference
CHR-101-100 EUDAMED

Identifiers

Primary DI / UDI-DI
04255597800748 EUDAMED
Basic UDI-DI
42555978DETECTIONPP EUDAMED
Direct Marketing DI
04255597800748 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, 2 components by biocyc Biotechnologie GmbH & Co. KG — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
biocyc Biotechnologie GmbH & Co. KG
EUDAMED SRN
DE-MF-000031533

Sources (1)

  • EUDAMED c0c3812a-c651-4e59-975d-943b413ac8b6 61 fields · synced Jun 18, 2026