Skip to content

Lyfo Disk™ 0895l

by Microbiologics, Inc.

Ref [0895L] LYFO DISK™ E. gallinarum ATCC 49573™Model 0895

Lyfo Disk™ 0895l is a device classified as Class B in the EU and Class I in the US made by Microbiologics, Inc., listed in FDA GUDID since 30 Apr 2020 (UDI-DI 10845357021998), registry data as of 23 Oct 2026.

Listed No authorization on record

CE, no status data

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10845357021998 UDI-DI Date30 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

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
0895 EUDAMED
[0895L] LYFO DISK™ E. gallinarum ATCC 49573™ EUDAMED
0895L GUDID
Primary DI / UDI-DI
10845357021998
Basic UDI-DI
084535700895AZ
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 registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
0895
[0895L] LYFO DISK™ E. gallinarum ATCC 49573™
GUDID
0895L
Device classEUDAMED
Class B
GUDID
Class I

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

Similar devices in this category

Other devices filed under MICROBIOLOGY (CULTURE).

Other devices from Microbiologics, Inc.

See all devices from Microbiologics, Inc. →

Properties

  • Single use
  • Contains substances of microbial origin
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)