VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183524 FDA 510(k)
- FDA Product Code
- LON FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1645 FDA 510(k)
- Regulation Number
- 866.1645 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Vitek2 AST-Gram Negative Delafloxacin is an automated antimicrobial susceptibility test system designed for Gram‑negative bacilli. It provides short‑incubation, in‑vitro determination of bacterial susceptibility to delafloxacin using a standardized test card.
The test card is intended for use with the Vitek® 2 and Vitek® 2 Compact Systems as a laboratory aid. It contains delafloxacin concentrations of 0.06, 0.25, 0.5 and 2 µg/mL, with a reporting range of ≤0.06‑≥4 µg/mL for Enterobacteriaceae and ≤0.12‑≥4 µg/mL for Pseudomonas aeruginosa. The device is cleared under FDA 510(k) (K183524), classified as Class II with product code LON.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) (K183524 ..., VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) by bioMerieux ..., K183524 FDA 510(k) - VITEK2 AST-Gram Negative Delafloxacin (...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183524 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
- FDA Applicant
- bioMerieux, Inc.
Sources (1)
- FDA 510(k) K183524 24 fields · synced Oct 6, 2026