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Diagnostic BioSystems RMPD070

by Diagnostic BioSystems

Ref RMPD070Model Primary Antibodies

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

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00846405010349 Basic UDI-DI 00846405010349UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846405010349 UDI-DI Date7 Jun 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Wilms Tumor WT, Clone EP122, 6 ml EUDAMED
Diagnostic BioSystems GUDID
Generic Name
Wilms tumour protein IVD, antibody
Device Name
Primary Antibodies
Model / Reference
RMPD070, Primary Antibodies
Primary DI / UDI-DI
00846405010349 EUDAMED
00846405009695 GUDID
Basic UDI-DI
B-00846405010349
FDA Product Code
NJT
EMDN Code
W0102010105 Immunoglobulin g
GMDN Term
Wilms tumour protein IVD, antibody
Device Class
Class IVD General EUDAMED
Class I GUDID
Regulation Number
864.1860
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00846405010349
GUDID
00846405009695
Device ClassEUDAMED
Class IVD General
GUDID
Class I

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Properties

  • Single Use
  • Reagent
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Implantable: No
  • Contains Latex: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No