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D3 DFA Chlamydiae Kit

by Diagnostic Hybrids, Inc.

Ref 01-040000Model D3

D3 DFA Chlamydiae Kit (01-040000) is a device classified as IVD General (EU), Class I (US) made by Diagnostic Hybrids, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-30014613330547), cleared under FDA 510(k) K063675 on 24 Sep 2007 and listed in FDA GUDID since 30 Aug 2018 (UDI-DI 30014613330547), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K063675

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-30014613330547 Basic UDI-DI 30014613330547UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613330547 UDI-DI Date30 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK063675 Date24 Sep 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30014613330547 registered 22 Oct 2026 Active
  • FDA 510(k) K063675 decided 24 Sep 2007 Active
  • FDA GUDID UDI-DI 30014613330547 listed 30 Aug 2018 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K063675
  2. Listed FDA GUDID 30014613330547
  3. Registered EUDAMED B-30014613330547

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
D3 DFA Chlamydiae Culture Confirmation Kit EUDAMED
D3 GUDID
Generic name
Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay
Device name
DFA Chlamydiae Culture Confirmation Kit
Model / Ref / Catalog
D3, 01-040000, DFA Chlamydiae Kit
Primary DI / UDI-DI
30014613330547
Basic UDI-DI
B-30014613330547
510(k) Number
FDA product code
LJP
EMDN code
W0105010199 Chlamydia reagents - other
GMDN term
Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
866.3120
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
D3
01-040000
GUDID
DFA Chlamydiae Kit
Device classEUDAMED
Class IVD General
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay

Similar devices in this category

Other devices filed under CHLAMYDIA.

Other devices from Diagnostic Hybrids, Inc.

See all devices from Diagnostic Hybrids, Inc. →

Properties

  • Single use
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)