Skip to content

PolyQ Stain 1 step detection system goat anti-mouse/rabbit AP

by biocyc Biotechnologie GmbH & Co. KG 3 variants

Ref DS-112-050, DSK-111-500, DSK-112-500, DS-112-000, DSK-111-000, DS-112-015, DS-111-005, DSk-112-050, DSK-112-015, DSK-111-005, DSK-111-015, DS-112-500, DS-111-015, DSK-112-050

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42555978DETECTIONPP Basic UDI-DI Date19 Sep 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Trade Name
PolyQ Stain 1 step detection system goat anti-mouse/rabbit AP
PolyQ Stain 1 step detection system goat anti-mouse/rabbit HRP, Peroxidase quench, DAB kit
PolyQ Stain 1 step detection system goat anti-mouse/rabbit AP, Permanent Red kit
PolyQ Stain 1 step detection system goat anti-mouse/rabbit HRP
Device Name
detection systems
Model / Reference
DS-112-050, DSK-111-500, DSK-112-500, DS-112-000, DSK-111-000, DS-112-015, DS-111-005, DSk-112-050, DSK-112-015, DSK-111-005, DSK-111-015, DS-112-500, DS-111-015
Primary DI / UDI-DI
04255597800885, 04255597800854, 04255597801936, 04255597800915, 04255597800861, 04255597800878, 04255597801738, 04255597801912, 04255597801905, 04255597801721, 04255597800823, 04255597800908, 04255597800779
Basic UDI-DI
42555978DETECTIONPP, 42555978DETECDSK111RS, 42555978DETECDSK112RU, 42555978DETECDS112Y7, 42555978DETECDS111Y5
Direct Marketing DI
04255597800885
04255597800854
04255597801936
04255597800915
04255597800861
04255597800878
04255597801738
04255597801905
04255597801721
04255597800823
04255597800908
04255597800779
04255597801912
EMDN Code
W01030711 Immunohistology kits
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000031533

Related devices

Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Other devices from biocyc Biotechnologie GmbH & Co. KG

See all devices from biocyc Biotechnologie GmbH & Co. KG →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No