KWIK-STIK™ and LYFO DISK™
EUDAMEDFDA UDIClass B (EU MDR)
Identity
- Trade Name
- KWIK-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™ H. influenzae ATCC 49766™ FDA UDI
- Model / Reference
- 0919 EUDAMED[0919U] KWIK-STIK™ H. influenzae ATCC 49766™ EUDAMED0919U FDA UDI
- Description
- KWIK-STIK™ H. influenzae ATCC 49766™ FDA UDI
Identifiers
- Catalog Number
- 0919U FDA UDI
- Primary DI / UDI-DI
- 10845357022520 EUDAMEDFDA UDI
- Basic UDI-DI
- 084535700919AN EUDAMED
- FDA Product Code
- JTR 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
- 866.2480 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
No
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
KWIK-STIK™ and LYFO DISK™ by Microbiologics, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple bacteria species culture isolate identification control IVD, kit.
- QC Sets and Panels: KWIK-STIK™ — MICROBIOLOGICS INC. · Class B
- CQI KD-Col/PM/Susp-E.h Fv — KaliDiv · Class B
- KWIK-STIK™ and LYFO DISK™ — MICROBIOLOGICS, INC. · Class B
- Microbiology Slides — MICROBIOLOGICS, INC. · Class B
- KWIK-STIK™ and LYFO DISK™ — MICROBIOLOGICS, INC. · Class B
- LYFO DISK™ — MICROBIOLOGICS, INC. · Class I
- KWIK-STIK™ and LYFO DISK™ — MICROBIOLOGICS, INC. · Class B
- KWIK-STIK™ and LYFO DISK™ — MICROBIOLOGICS, INC. · Class B
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 084535700919AN | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microbiologics, INC.
- EUDAMED SRN
- US-MF-000000466
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 4fb2bc3a-f094-49a4-a304-77dea8f886c7 61 fields · synced Jun 18, 2026
- FDA UDI 041de5b0-9d54-404e-a1c6-22f19731fe99 36 fields · synced May 26, 2026