Identity
- Trade Name
- ETEST® Amoxicillin (AC) EUDAMEDFDA UDI
- Generic Name
- Antibacterial minimum inhibitory concentration (MIC) IVD FDA UDI
- Device Name
- ETEST® Amoxicillin (AC) EUDAMEDEtest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination. FDA UDI
- Model / Reference
- 8308947 EUDAMED542784 EUDAMEDETEST® Amoxicillin (AC) FDA UDI
- Description
- Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026549909 EUDAMEDFDA UDI03573026620189 EUDAMED
- Basic UDI-DI
- 357302BUDI000617TR EUDAMED357302BUDI000762U3 EUDAMED
- Unit of Use DI
- 03573026620585 EUDAMED
- 510(k) Number
- K960991 FDA UDI
- FDA Product Code
- JWY FDA UDI
- EMDN Code
- W0104080501 MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST) EUDAMED
- GMDN Term
- Antibacterial 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: Antibacterial minimum inhibitory concentration (MIC) IVD
ETEST® Amoxicillin (AC) by Biomerieux Sa — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antibacterial minimum inhibitory concentration (MIC) IVD.
- MOXIFLOXACIN — BioMaxima Spółka Akcyjna · Class B
- ETEST® Benzylpenicillin (PG) — BIOMERIEUX , INC. · Class II
- AMPHOTERICIN B — BioMaxima Spółka Akcyjna · Class B
- ETEST® Minocycline (MC) — BIOMERIEUX , INC. · Class II
- CEFTOLOZANE-TAZOBACTAM — BioMaxima Spółka Akcyjna · Class B
- Etest® TIGECYCLINE — BIOMERIEUX , INC. · Class II
- VANCOMYCIN — BioMaxima Spółka Akcyjna · Class B
- ETEST® Ertapenem (ETP) — BIOMERIEUX , INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 357302BUDI000617TR | 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
- bioMérieux SA
- EUDAMED SRN
- FR-MF-000004436
Sources (4)
- EUDAMED fc09cfbc-f43f-4df6-bd4d-17fb1ed4e8d2 61 fields · synced Jul 30, 2026
- FDA UDI 618600ff-d742-42d3-861b-17b384e74cef 35 fields · synced May 30, 2026
- EUDAMED 6353ba23-fd83-4252-b585-60f6f951fad5 61 fields · synced Jun 14, 2026
- EUDAMED 9d2dc71b-ea7b-4bb2-921a-bce7fbcdd066 61 fields · synced Jul 15, 2026