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Diagnostic BioSystems F005-01

by Diagnostic BioSystems

Ref F005-05Model 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00846405014033 Basic UDI-DI 00846405014033UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846405014033 UDI-DI Date8 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  • Withdrawn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
C4c-FITC EUDAMED
Diagnostic BioSystems GUDID
Generic Name
Complement components C4/C4c IVD, antibody
Device Name
Primary Antibodies
Model / Reference
Primary Antibodies EUDAMED
F005-05 EUDAMED
F005-01 GUDID
Primary DI / UDI-DI
00846405014033
Basic UDI-DI
B-00846405014033
FDA Product Code
NJT
EMDN Code
W0102010109 Kappa and lambda chain
GMDN Term
Complement components C4/C4c IVD, antibody
Device Class
Class IVD General EUDAMED
Class I GUDID
Regulation Number
864.1860
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Primary Antibodies
F005-05
GUDID
F005-01
Device ClassEUDAMED
Class IVD General
GUDID
Class I

Other devices from Diagnostic BioSystems

See all devices from Diagnostic BioSystems →

Properties

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

Other properties (17)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No