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KWIK-STIK™ and LYFO DISK™
EUDAMEDFDA UDIClass B (EU MDR)
Ref [01063L] LYFO DISK™ C. gattii (B) ATCC 34877™Model 01063
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 (B) ATCC 34877™ FDA UDI
- Model / Reference
- 01063 EUDAMED[01063L] LYFO DISK™ C. gattii (B) ATCC 34877™ EUDAMED01063L FDA UDI
- Description
- LYFO DISK™ C. gattii (B) ATCC 34877™ FDA UDI
Identifiers
- Catalog Number
- 01063L FDA UDI
- Primary DI / UDI-DI
- 10845357032796 EUDAMEDFDA UDI
- Basic UDI-DI
- 0845357001063WG 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
KWIK-STIK™ and LYFO DISK™ by Microbiologics, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0845357001063WG | 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 ab5de86b-f535-4907-9d89-d3c226736624 61 fields · synced Jun 19, 2026
- FDA UDI d9d49376-5d32-42d2-9625-51700b790dc6 36 fields · synced May 29, 2026