KWIK-STIK™ and LYFO DISK™
EUDAMEDFDA UDIClass B (EU MDR)
Identity
- Trade Name
- LYFO DISK™ FDA UDI
- Generic Name
- Multiple bacteria species culture isolate identification control IVD, kit FDA UDI
- Device Name
- KWIK-STIK™ and LYFO DISK™ EUDAMEDLYFO DISK™ C. gattii ATCC MYA-4560™ FDA UDI
- Model / Reference
- 01051 EUDAMED[01051L] LYFO DISK™ C. gattii ATCC MYA-4560™ EUDAMED01051L FDA UDI
- Description
- LYFO DISK™ C. gattii ATCC MYA-4560™ FDA UDI
Identifiers
- Catalog Number
- 01051L FDA UDI
- Primary DI / UDI-DI
- 10845357032291 EUDAMEDFDA UDI
- Basic UDI-DI
- 0845357001051W9 EUDAMED
- FDA Product Code
- JTR FDA UDI
- EMDN Code
- W01040699 CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER 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
Category: Multiple bacteria species culture isolate identification control IVD, kit
KWIK-STIK™ and LYFO DISK™ by Microbiologics, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0845357001051W9 | 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 ddb3c665-eb95-4b84-b701-01fed5af7fcb 61 fields · synced Jul 9, 2026
- FDA UDI ad2bcaff-b08a-45ce-9d26-ecb889551c9d 36 fields · synced May 30, 2026