QC Sets and Panels: KWIK-STIK™
EUDAMEDFDA UDIClass B (EU MDR)
Identity
- Trade Name
- QC Sets and Panels: KWIK-STIK™ FDA UDI
- Generic Name
- Multiple bacteria species culture isolate identification control IVD, kit FDA UDI
- Device Name
- QC Sets and Panels: KWIK-STIK™ EUDAMEDQC Sets and Panels: KWIK-STIK™ Cdiff Verification Panel (Live Culture) FDA UDI
- Model / Reference
- 8243 EUDAMEDFDA UDI[8243] Cdiff Verification Panel (Live Culture) EUDAMED
- Description
- QC Sets and Panels: KWIK-STIK™ Cdiff Verification Panel (Live Culture) FDA UDI
Identifiers
- Catalog Number
- 8243 FDA UDI
- Primary DI / UDI-DI
- 70845357043329 EUDAMEDFDA UDI
- Basic UDI-DI
- 084535708243B8 EUDAMED
- FDA Product Code
- OHQ FDA UDI
- EMDN Code
- W01040601 QC STRAINS BACTERIOLOGY 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
- 862.1660 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
Yes
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
QC Sets and Panels: KWIK-STIK™ 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 | 084535708243B8 | 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 1f957b0c-eae4-4c8e-bb17-0b484d0888cd 61 fields · synced May 31, 2026
- FDA UDI 59f72462-a84b-4ce0-83ce-c44887b9ec01 36 fields · synced May 30, 2026