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KWIK-STIK™ and LYFO DISK™

by Microbiologics, INC. United States EUDAMEDGUDID

Ref [0259U] KWIK-STIK™ P. acidilactici ATCC 8042™Model 0259 Product code JTREMDN W01040601

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0845357002599X Basic UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10845357004618 UDI-DIDate30 Apr 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Kwik-Stik™
Generic Name
Multiple bacteria species culture isolate identification control IVD, kit
Device Name
KWIK-STIK™ and LYFO DISK™
Model / Ref / Catalog
0259 EUDAMED
[0259U] KWIK-STIK™ P. acidilactici ATCC 8042™ EUDAMED
0259U GUDID
Primary DI / UDI-DI
10845357004618
Basic UDI-DI
0845357002599X
FDA Product Code
JTR
EMDN Code
W01040601 Qc strains bacteriology
GMDN Term
Multiple bacteria species culture isolate identification control IVD, kit
Device Class
Class B EUDAMED
Class I GUDID
Regulation Number
866.2480
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
0259
[0259U] KWIK-STIK™ P. acidilactici ATCC 8042™
GUDID
0259U
Device ClassEUDAMED
Class B
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000000466
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

Related devices

Category: Multiple bacteria species culture isolate identification control IVD, kit

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Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Microbial Substances
  • 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
  • Reagent: 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

Sources (2)

  • EUDAMED d1107abd-0f46-4538-8db3-3036724e2e4d 61 fields · synced 22 Oct 2026
  • FDA UDI 5dff412d-bb21-436f-85fe-18566220996d 36 fields · synced 30 May 2026