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KWIK-STIK™ and LYFO DISK™
EUDAMEDFDA UDIClass B (EU MDR)
Ref [0317U] KWIK-STIK™ C. sporogenes ATCC 19404™Model 0317
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™ C. sporogenes ATCC 19404™ FDA UDI
- Model / Reference
- 0317 EUDAMED[0317U] KWIK-STIK™ C. sporogenes ATCC 19404™ EUDAMED0317U FDA UDI
- Description
- KWIK-STIK™ C. sporogenes ATCC 19404™ FDA UDI
Identifiers
- Catalog Number
- 0317U FDA UDI
- Primary DI / UDI-DI
- 10845357006155 EUDAMEDFDA UDI
- Basic UDI-DI
- 0845357003179L 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
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 | 0845357003179L | 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 15e535b9-3c63-4f99-99b8-b550c27a78bb 61 fields · synced Jul 9, 2026
- FDA UDI caf9e1ee-823f-4380-b954-f6ff7efbc6cd 36 fields · synced May 30, 2026