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Lyfo Disk™ 0815l

by Microbiologics, Inc.

Ref [0815L] LYFO DISK™ L. ivanovii ATCC 19119™Model 0815

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

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/IVDR EUDAMED Number084535700815A9 Basic UDI-DI 10845357019919UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10845357019919 UDI-DI Date30 Apr 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Lyfo Disk™
Generic Name
Multiple bacteria species culture isolate identification control IVD, kit
Device Name
KWIK-STIK™ and LYFO DISK™
Model / Ref / Catalog
0815 EUDAMED
[0815L] LYFO DISK™ L. ivanovii ATCC 19119™ EUDAMED
0815L GUDID
Primary DI / UDI-DI
10845357019919
Basic UDI-DI
084535700815A9
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
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
0815
[0815L] LYFO DISK™ L. ivanovii ATCC 19119™
GUDID
0815L
Device ClassEUDAMED
Class B
GUDID
Class I

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Properties

  • 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