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PolyQ Stain 2 step detection system goat anti-mouse/rabbit AP

by biocyc Biotechnologie GmbH & Co. KG 5 variants

Ref DS-212-005, DSK-211-100, DS-211-100, DS-211-000, DSK-211-050, DS-212-100, DS-211-015, DS-211-050, DSK-212-005, DSK-211-500, DSK-212-500

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  • Withdrawn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 2 step detection system goat anti-mouse/rabbit AP
PolyQ Stain 2 step detection system goat anti-mouse/rabbit HRP, Peroxidase quench, DAB Kit
PolyQ Stain 2 step detection system goat anti-mouse/rabbit HRP
PolyQ Stain 2 step detection system goat anti-mouse/rabbit AP, Permanent Red kit
Device Name
detection systems
Detetction Systems
Model / Reference
DS-212-005, DSK-211-100, DS-211-100, DS-211-000, DSK-211-050, DS-212-100, DS-211-015, DS-211-050, DSK-212-005, DSK-211-500, DSK-212-500
Primary DI / UDI-DI
04255597801639, 04255597801295, 04255597801240, 04255597801264, 04255597801288, 04255597801349, 04255597801226, 04255597801233, 04255597801837, 04255597801301, 04255597801875
Basic UDI-DI
42555978DETECTIONPP, 42555978DETECDS211YA, 42555978DETECDSK211RX, 42555978DETECDSK212RZ, 42555978DETECDS212YC
Direct Marketing DI
04255597801639
04255597801295
04255597801240
04255597801264
04255597801288
04255597801349
04255597801226
04255597801233
04255597801837
04255597801301
04255597801875
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

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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