Identity
- Trade Name
- ETEST® Gentamicin (GM) EUDAMEDFDA UDI
- Generic Name
- Antibacterial minimum inhibitory concentration (MIC) IVD FDA UDI
- Device Name
- ETEST® Gentamicin (GM) EUDAMEDETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria FDA UDI
- Model / Reference
- 543030 EUDAMEDETEST® Gentamicin (GM) FDA UDI
- Description
- ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026624835 EUDAMED03573026624842 FDA UDI
- Basic UDI-DI
- 357302BUDI000696UF EUDAMED
- 510(k) Number
- K913459 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
Yes
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® Gentamicin (GM) by Biomerieux , Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K913459 also covers:
- ETEST® Ampicillin (AM) — BIOMERIEUX , INC.
- ETEST® Ampicillin (AM) — BIOMERIEUX , INC.
- ETEST® Cefoxitin (FX) — BIOMERIEUX , INC.
- ETEST® Cefoxitin (FX) — BIOMERIEUX , INC.
- ETEST® Cephalothin (CE) — BIOMERIEUX , INC.
- ETEST® Clindamycin (CM) — BIOMERIEUX , INC.
- ETEST® Clindamycin (CM) — BIOMERIEUX , INC.
- ETEST® Erythromycin (EM) — BIOMERIEUX , INC.
- ETEST® Erythromycin (EM) — BIOMERIEUX , INC.
- ETEST® Gentamicin (GM) — BIOMERIEUX , INC.
- ETEST® Gentamicin (GM) — BIOMERIEUX , INC.
- ETEST® Metronidazole (MZ) — BIOMERIEUX , INC.
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 42b6a383-79a5-4f32-83f3-581bb321b4d2 35 fields · synced Jul 11, 2026
- EUDAMED 340540e8-5fc7-440f-9463-d54aa7a6f9e2 61 fields · synced Jul 11, 2026