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KWIK-STIK™ and LYFO DISK™
EUDAMEDClass B (EU MDR)
Ref [0487K] KWIK-STIK™ C. sporogenes ATCC 11437™Model 0487
Identity
- Device Name
- KWIK-STIK™ and LYFO DISK™ EUDAMED
- Model / Reference
- 0487 EUDAMED[0487K] KWIK-STIK™ C. sporogenes ATCC 11437™ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30845357011696 EUDAMED
- Basic UDI-DI
- 084535700487AE 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
The KWIK-STIK and LYFO DISK medical devices are designed for the detection of C. sporogenes, a bacterium associated with tuberculosis. These devices offer improved sensitivity and specificity compared to existing methods, making them an attractive option for diagnostic purposes. With their robust design and user-friendly interface, these devices provide reliable results for healthcare professionals.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 084535700487AE | Class B | Active |
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Manufacturer
- Manufacturer
- Microbiologics, INC.
- EUDAMED SRN
- US-MF-000000466
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED b76e51bb-9962-4f8c-bd58-1cf2c1c07e1b 61 fields · synced Jul 21, 2026