Lyfo Disk™
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- LYFO DISK™ FDA UDI
- Generic Name
- Multiple bacteria species culture isolate identification control IVD, kit FDA UDI
- Device Name
- KWIK-STIK™ and LYFO DISK™ EUDAMEDLYFO DISK™ S. agalactiae (B) NCTC 9993 FDA UDI
- Model / Reference
- 0710 EUDAMED[0710L] LYFO DISK™ S. agalactiae (B) NCTC 9993 EUDAMED0710L FDA UDI
- Description
- LYFO DISK™ S. agalactiae (B) NCTC 9993 FDA UDI
Identifiers
- Catalog Number
- 0710L FDA UDI
- Primary DI / UDI-DI
- 10845357017175 EUDAMEDFDA UDI
- Basic UDI-DI
- 0845357007109S 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
Lyfo Disk™ by Microbiologics, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Microbiologics, Inc.
Sources (2)
- FDA UDI c9e7491b-ab28-4159-978d-7a6b1008c8ba 36 fields · synced Jun 19, 2026
- EUDAMED edc4b4fa-eee0-41c4-ae6f-6c18afc701a0 61 fields · synced Jun 19, 2026