FDA.reportPublic FDA data

T2 BIOSYSTEMS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30100978673010097867T2 BIOSYSTEMS, INC.1N2020-04-25101 Hartwell Ave Lexington MA US 02421

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M70870049330T2Dx® - Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing.877-504-8282t2service@t2biosystems.com
M70880016893T2Candida® Reagent Trays - The T2Candida component that contains the refrigerated reagents used to perform the T2Candida panel.877-504-8282t2service@t2biosystems.com
M70880080720T2Bacteria® Reagent Trays - The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria Panel.877-504-8282t2service@t2biosystems.com
M70880080723T2Bacteria® Reagent Trays - The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria Panel.877-504-8282t2service@t2biosystems.com
M70885080730T2Bacteria® QCheck Positive Kit - Positive ASK Control, Positive EPE Control877-504-8282t2service@t2biosystems.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1818751863543275K173536T2Candida 1.1 PanelPII2017-12-12
1818751103124462K172708T2Bacteria PanelQBX2018-05-24
1818751644497325DEN140019T2CANDIDA AND T2DX INSTRUMENTPII2014-09-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PII22017-12-12
QBX12018-05-24

PMN#

GUDID#