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QC Sets and Panels: KWIK-STIK™ 2 Pack
EUDAMEDFDA UDIClass B (EU MDR)
Ref [5225P] Gram-Positive Blood Culture Control Panel (Live Culture)Model 5225P
Identity
- Trade Name
- QC Sets and Panels: KWIK-STIK™ 2 Pack FDA UDI
- Generic Name
- Multiple bacteria species culture isolate identification control IVD, kit FDA UDI
- Device Name
- QC Sets and Panels: KWIK-STIK™ 2 Pack EUDAMEDQC Sets and Panels: KWIK-STIK™ Gram-Positive Blood Culture Control Panel (Live Culture) FDA UDI
- Model / Reference
- 5225P EUDAMEDFDA UDI[5225P] Gram-Positive Blood Culture Control Panel (Live Culture) EUDAMED
- Description
- QC Sets and Panels: KWIK-STIK™ Gram-Positive Blood Culture Control Panel (Live Culture) FDA UDI
Identifiers
- Catalog Number
- 5225P FDA UDI
- Primary DI / UDI-DI
- 70845357037342 EUDAMEDFDA UDI
- Basic UDI-DI
- 084535705225AH 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
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
Yes
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
QC Sets and Panels: KWIK-STIK™ 2 Pack 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 | 084535705225AH | 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 71f92d86-7aeb-46bd-b2e3-fdbe1e308731 61 fields · synced Jul 11, 2026
- FDA UDI 96590bd4-3557-4ee3-9c11-9c25e09145cd 36 fields · synced May 30, 2026