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Syva® RapidTest d.a.u.® 3 10445358

by Siemens Healthcare Diagnostics Inc.

Ref 10445358Model DX_LS_LEGACY_00842768001291

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00842768001291 Basic UDI-DI 00842768001291UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768001291 UDI-DI Date24 Sep 2016ListedStatusListed 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  • Withdrawn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
Syva Rapid Test d.a.u. 3 THC/COC/OPI EUDAMED
Syva® RapidTest d.a.u.® 3 GUDID
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Name
DX_LS_LEGACY_00842768001291
Model / Ref / Catalog
10445358, DX_LS_LEGACY_00842768001291, 6A179UL
Primary DI / UDI-DI
00842768001291
Basic UDI-DI
B-00842768001291
FDA Product Code
DIO, DJG, LDJ
EMDN Code
W0102160511 Multiple drugs of abuse/toxicology rt & poc
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
862.3250, 862.3650, 862.3870
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
GUDID
Class II

Related devices

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Other devices from Siemens Healthcare Diagnostics Inc.

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Properties

  • Single Use
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No