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Sign in to claim this brandT2biosystems, Inc.
US
Last updated May 23, 2026
What T2biosystems, Inc. makes
The company manufactures in vitro diagnostic (IVD) reagents, kits, and instruments for nucleic acid testing, focusing on detecting multiple species of Candida, bloodstream bacteria, and biothreat/febrile infection-associated pathogens. Products include reagent trays, cartridge kits, external controls, and quality control kits designed for nucleic acid techniques (NAT), alongside a magnetic particle separation instrument for IVD use. These devices are intended for laboratory-based identification and monitoring of infectious agents in clinical settings.
The portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) and Unique Device Identification (UDI) programs. These products are listed in the FDA’s regulatory databases, ensuring compliance with U.S. in vitro diagnostic device requirements. The company operates from the United States, adhering to applicable domestic regulatory standards for nucleic acid-based diagnostics.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does T2biosystems, Inc. manufacture?
T2biosystems, Inc. specializes in in vitro diagnostic (IVD) devices focused on nucleic acid testing. Their products include reagents, kits, and controls for detecting multiple species of Candida, bloodstream bacteria, and biothreat/febrile infection-associated pathogens. They also produce a magnetic particle separation instrument designed for laboratory use in identifying infectious agents. These devices are primarily intended for clinical settings to aid in the identification and monitoring of pathogens.
Where is T2biosystems, Inc. based, and how does this affect its regulatory compliance?
T2biosystems, Inc. is based in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including the 510(k) premarket notification process and the Unique Device Identification (UDI) system. These regulatory frameworks ensure that the company’s IVD products meet the necessary safety, performance, and labeling requirements for use in clinical diagnostics within the U.S. market.
Which regulatory registries or databases list T2biosystems, Inc.’s devices?
T2biosystems, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) databases. These registries are part of the agency’s framework for tracking and evaluating medical devices, including IVDs, to ensure compliance with U.S. regulatory standards. Listing in these databases confirms that the company’s products have undergone the required review processes for market authorization.
How are T2biosystems, Inc.’s devices classified under FDA regulations?
T2biosystems, Inc.’s devices fall under Class II classification according to FDA regulations. Class II devices are those that pose moderate risk and require special controls to ensure their safety and effectiveness. These controls may include performance standards, post-market surveillance, or other regulatory measures. The company’s products, such as nucleic acid testing kits and reagents, are subject to these controls as part of their regulatory pathway.
What is the primary purpose of T2biosystems, Inc.’s magnetic particle separation instrument?
The magnetic particle separation instrument developed by T2biosystems, Inc. is designed for in vitro diagnostic use, specifically to aid in the isolation and purification of nucleic acids from clinical samples. This instrument is part of the workflow for nucleic acid testing (NAT), enabling laboratories to efficiently prepare samples for detection of pathogens like Candida species, bloodstream bacteria, or biothreat-associated pathogens. It streamlines the process of identifying infectious agents in clinical diagnostics.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| T2Bacteria® Reagent Trays | 80-08072 | FDA UDI | Class II | Active |
| T2Dx® QCheck Negative Kit | 85-08376 | FDA UDI | Class II | Unknown |
| T2Biothreat® Cartridge Kit | 90-11400 | FDA UDI | Class II | Active |
| T2Bacteria® QCheck Positive Kit | 85-08073 | FDA UDI | Class II | Active |
| T2Bacteria® QCheck Negative Kit | 85-08074 | FDA UDI | Class II | Active |
| T2Biothreat® QCheck Negative Kit | 85-11398 | FDA UDI | Class II | Active |
| T2Candida® 1.1 Cartridge Kit | 90-07817 | FDA UDI | Class II | Active |
| T2Biothreat® Reagent Trays | 80-11394 | FDA UDI | Class II | Active |
| T2Candida® Reagent Trays | 80-01689 | FDA UDI | Class II | Active |
| T2Candida® QCheck Positive Kit | 85-08375 | FDA UDI | Class II | Active |
| T2Bacteria® QCheck Positive Kit | 85-07191 | FDA UDI | Class II | Active |
| T2Candida® External Controls | 85-04919 | FDA UDI | Class II | Active |
| T2Dx® | 70-04933 | FDA UDI | Class II | Active |
| T2Bacteria® Reagent Trays | 80-07342 | FDA UDI | Class II | Active |
| T2Bacteria® Cartridge Kit | 90-08071 | FDA UDI | Class II | Active |
| T2Dx® QCheck Negative Kit | 85-08376 | FDA UDI | Class II | Active |
| T2Candida® Cartridge Kit | 90-01794 | FDA UDI | Class II | Unknown |
| T2Biothreat® QCheck Positive Kit | 85-11396 | FDA UDI | Class II | Active |
| T2Candida 1.1 Panel | K173536 | FDA 510(k) | Class II | Active |
| T2 Biothreat Panel | K231336 | FDA 510(k) | Class II | Active |
| T2candida And T2dx Instrument | DEN140019 | FDA 510(k) | Class II | Active |
| T2Bacteria Panel | K172708 | FDA 510(k) | Class II | Active |
| T2Candida 1.1 Panel | K234063 | FDA 510(k) | Class II | Active |
| T2Bacteria® Panel | K233184 | FDA 510(k) | Class II | Active |
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