T2CANDIDA and T2DX Instrument
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- DEN140019 FDA 510(k)
- FDA Product Code
- PII FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3960 FDA 510(k)
- Regulation Number
- 866.3960 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The T2Candida and T2DX Instrument is a nucleic acid detection system for identifying Candida species and other bacterial pathogens from blood samples. Classified as a Candida Species Nucleic Acid Detection System, it employs molecular diagnostics to enable rapid, direct detection of infectious agents in whole blood, supporting targeted sepsis management.
This benchtop instrument operates as a fully automated, random-access system with a user-friendly touchscreen interface. Supplied sterile and intended for single-use applications, it processes samples within 10 minutes or less without batching requirements. Authorized under FDA 510(k) clearance (DEN140019) and classified as a Class II device, it adheres to microbiology standards for clinical laboratory use.
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: T2Dx Instrument | T2 Biosystems, Inc. - medical-xprt.com, PDF T2Dx® Diagnostics - bmgrp.eu, T2CANDIDA AND T2DX INSTRUMENT (DEN140019) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN140019 | Class II | Active |
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Manufacturer
- Manufacturer
- T2biosystems, Inc.
Sources (1)
- FDA 510(k) DEN140019 24 fields · synced Sep 19, 2026