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UltraVision Quanto Detection System HRP DAB 15mL

by Richard-Allan Scientific LLC

Ref TL-015-QHD

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0673693RAS059S6 Basic UDI-DI 00673693461108UDI-DIDate21 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00673693461108 UDI-DI Date11 Apr 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
UltraVision Quanto Detection System HRP DAB 15mL EUDAMED
Thermo Scientific GUDID
Generic Name
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Device Name
UltraVision Quanto Detection Systems
Model / Reference
TL-015-QHD
Primary DI / UDI-DI
00673693461108
Basic UDI-DI
0673693RAS059S6
Direct Marketing DI
00673693461108
FDA Product Code
NJT
EMDN Code
W01030711 Immunohistology kits
GMDN Term
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.1860
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 15 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000008261
Authorised representative
Epredia Netherlands B.V. NL-AR-000001488

Related devices

Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Other devices from Richard-Allan Scientific LLC

See all devices from Richard-Allan Scientific LLC →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No