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Immunalysis 311UR-0100

by Immunalysis Corporation

Ref 311UR-0100

Immunalysis 311UR-0100 is a methamphetamine-specific IVD (EU IVDD general IVD; FDA Class II; FDA product code LAF, Gas chromatography, methamphetamine) made by Immunalysis Corporation, registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI B-00840937101940), cleared under FDA 510(k) K153693 on 18 Mar 2016 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00840937101940), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153693

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00840937101940 Basic UDI-DI 00840937101940UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840937101940 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153693 Date18 Mar 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00840937101940 registered 20 Aug 2026 Active
  • FDA 510(k) K153693 decided 18 Mar 2016 Active
  • FDA GUDID UDI-DI 00840937101940 listed 31 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153693
  2. Listed FDA GUDID 00840937101940
  3. Registered EUDAMED B-00840937101940

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  • Withdrawn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
Immunalysis
Generic name
Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
311UR-0100
Primary DI / UDI-DI
00840937101940
Basic UDI-DI
B-00840937101940
510(k) Number
FDA product code
LAF
EMDN code
W0102090102 Amphetamine/methamphetamine specific
GMDN term
Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.3610
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

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

Related devices

Category: Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K153693)

Similar devices in this category

Other devices filed under AMPHETAMINE/METHAMPHETAMINE SPECIFIC.

Other devices from Immunalysis Corporation

See all devices from Immunalysis Corporation →

Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)