Identity
- Trade Name
- ETEST® Ceftriaxone (TXL) FDA UDI
- Generic Name
- Antibacterial minimum inhibitory concentration (MIC) IVD FDA UDI
- Device Name
- 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
- Model / Reference
- ETEST® Ceftriaxone (TXL) 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
- 03573026619992 FDA UDI
- 510(k) Number
- K981139 FDA UDI
- FDA Product Code
- JWY FDA UDI
- GMDN Term
- Antibacterial minimum inhibitory concentration (MIC) IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Antibacterial minimum inhibitory concentration (MIC) IVD
ETEST® Ceftriaxone (TXL) by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antibacterial minimum inhibitory concentration (MIC) IVD.
- MOXIFLOXACIN — BioMaxima Spółka Akcyjna · Class B
- AMPHOTERICIN B — BioMaxima Spółka Akcyjna · Class B
- CEFTOLOZANE-TAZOBACTAM — BioMaxima Spółka Akcyjna · Class B
- VANCOMYCIN — BioMaxima Spółka Akcyjna · Class B
- CEFTAZIDIME — BioMaxima Spółka Akcyjna · Class B
- AMPICILLIN-SULBACTAM — BioMaxima Spółka Akcyjna · Class B
- CEFOTAXIME — BioMaxima Spółka Akcyjna · Class B
- AZT — Diagnostics s.r.o. · IVD General
Cleared under the same submission
K981139 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI dde023e5-34a4-4c18-8b6c-66312bb57e8e 35 fields · synced May 30, 2026