Identity
- Trade Name
- ETEST® Itraconazole (IT) EUDAMEDFDA UDI
- Generic Name
- Antifungal minimum inhibitory concentration (MIC) IVD FDA UDI
- Device Name
- ETEST® Itraconazole (IT) EUDAMEDEtest is a quantitative technique for determining susceptibility of clinically significant yeast. It provides a gradient of 15 doubling dilutions for MIC determination. FDA UDI
- Model / Reference
- 8308993 EUDAMEDETEST® Itraconazole (IT) FDA UDI
- Description
- Etest is a quantitative technique for determining susceptibility of clinically significant yeast. It provides a gradient of 15 doubling dilutions for MIC determination. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026550363 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000787UK EUDAMED
- 510(k) Number
- K040560 FDA UDI
- FDA Product Code
- NGZ FDA UDI
- EMDN Code
- W010403060101 SUSCEPTIBILITY TESTING SYSTEMS FOR YEASTS AND FUNGI - MANUAL EUDAMED
- GMDN Term
- Antifungal minimum inhibitory concentration (MIC) IVD FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.1640 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
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Antifungal minimum inhibitory concentration (MIC) IVD
ETEST® Itraconazole (IT) by Biomerieux , Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Antifungal minimum inhibitory concentration (MIC) IVD.
- ETEST® Flucytosine (FC) — BIOMERIEUX , INC. · Class II
- ETEST® Fluconazole (FL) — BIOMERIEUX , INC. · Class II
- ETEST® Fluconazole (FL) — BIOMERIEUX , INC. · Class II
- ETEST® Voriconazole (VO) — BIOMERIEUX , INC. · Class II
Cleared under the same submission
K040560 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (2)
- FDA UDI 89fd8ba0-4b8d-4056-b33a-f1cf33a69e7e 35 fields · synced Oct 7, 2026
- EUDAMED 4b7cb11e-b72a-438a-9d0b-1bdf319177a2 61 fields · synced Jul 9, 2026