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KWIK-STIK™ and LYFO DISK™

EUDAMED

Class B (EU MDR)

Ref [0435P] KWIK-STIK™ S. pneumoniae ATCC 27336™Model 0435

by Microbiologics, INC.

Identity

Device Name
KWIK-STIK™ and LYFO DISK™ EUDAMED
Model / Reference
0435 EUDAMED
[0435P] KWIK-STIK™ S. pneumoniae ATCC 27336™ EUDAMED

Identifiers

Primary DI / UDI-DI
20845357010050 EUDAMED
Basic UDI-DI
0845357004359T EUDAMED
EMDN Code
W01040601 QC STRAINS BACTERIOLOGY EUDAMED

Classification

Device Class
Class B EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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

KWIK-STIK™ and LYFO DISK™ by Microbiologics, Inc. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Multiple bacteria species culture isolate identification control IVD, kit.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Microbiologics, INC.
EUDAMED SRN
US-MF-000000466
Authorised Representative
MediMark Europe Sarl. FR-AR-000000182

Sources (1)

  • EUDAMED be85a059-6637-408d-b81d-ae6ac8bbd18a 61 fields · synced Jun 19, 2026