KWIK-STIK™ and LYFO DISK™
EUDAMEDFDA UDIClass B (EU MDR)
Identity
- Trade Name
- KWIK-STIK™ and LYFO DISK™ EUDAMEDKWIK-STIK™ FDA UDI
- Generic Name
- Multiple bacteria species culture isolate identification control IVD, kit FDA UDI
- Device Name
- KWIK-STIK™ and LYFO DISK™ EUDAMEDKWIK-STIK™ E. faecalis ATCC 19433™ FDA UDI
- Model / Reference
- 0367 EUDAMED[0367U] KWIK-STIK™ E. faecalis ATCC 19433™ EUDAMED0367U FDA UDI
- Description
- KWIK-STIK™ E. faecalis ATCC 19433™ FDA UDI
Identifiers
- Catalog Number
- 0367U FDA UDI
- Primary DI / UDI-DI
- 10845357007923 EUDAMEDFDA UDI
- Basic UDI-DI
- 084535700367A3 EUDAMED
- FDA Product Code
- JTR FDA UDI
- EMDN Code
- W0105080801 BACTERIOLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Multiple bacteria species culture isolate identification control IVD, kit FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2480 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
Yes
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
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
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The KWIK-STIK and LYFO DISK are medical devices used in endoscopic procedures for diagnostic and therapeutic purposes. The KWIK-STIK device is designed for use with certain pathogens, including E. faecalis, while the LYFO DISK is a sterile implantable device that can be used for various applications. Both devices undergo rigorous testing and evaluation before being approved for use on patients.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 084535700367A3 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Microbiologics, INC.
- EUDAMED SRN
- US-MF-000000466
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 2851c3e2-e310-457b-9e32-33bb4a56dc29 61 fields · synced Jul 9, 2026
- FDA UDI ae0b1457-3c85-447c-a37f-8d37ede17e35 36 fields · synced May 30, 2026