Identity
- Trade Name
- ETEST® Voriconazole (VO) EUDAMEDFDA UDI
- Generic Name
- Antifungal minimum inhibitory concentration (MIC) IVD FDA UDI
- Device Name
- ETEST® Voriconazole (VO) 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
- 8309008 EUDAMEDETEST® Voriconazole (VO) 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
- 03573026550516 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000724TT EUDAMED
- 510(k) Number
- K082534 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® Voriconazole (VO) by Biomerieux , Inc. — Class II — 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 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 61d0de52-1332-4c0b-aa76-8ca0a80a8b81 35 fields · synced Oct 6, 2026
- EUDAMED 4196d2c9-87d2-4f9f-baf9-4bbbfebdd201 61 fields · synced Jul 20, 2026