T2 BIOSYSTEMS, INC.

Address:101 Hartwell Ave,Lexington,MA,02421,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Candida Species Nucleic Acid Detection System (PII) (6) Direct Blood Bacterial Nucleic Acid Detection System (QBX) (3) Instrumentation For Clinical Multiplex Test Systems (NSU) (1)

Premarket Exempt

Clear

T2Dx® - M70870049330 Catalog Number :

Device Description : Instrument is a multiplex instrument that uses molecular amplification and magne Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing.

Device Class : 2

Duns Number: 803126320

Premarket Exempt : No

Product Code : NSU

Prescription Use : Yes

Device Count : 1

T2Candida® Reagent Trays - M70880016893 Catalog Number :

Device Description : The T2Candida component that contains the refrigerated reagents used to perform The T2Candida component that contains the refrigerated reagents used to perform the T2Candida panel.

Device Class :

Duns Number: 803126320

Premarket Exempt : No

Product Code : PII

Prescription Use : Yes

Device Count : 12

T2Bacteria® Reagent Trays - M70880073423 Catalog Number :

Device Description : The T2Bacteria component that contains the refrigerated reagents used to perform The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria panel.

Device Class :

Duns Number: 803126320

Premarket Exempt : No

Product Code : QBX

Prescription Use : Yes

Device Count : 12

T2Candida® External Controls - M70885049190 Catalog Number :

Device Description : IVD Positive APG, Positive TPK, Negative EDTA Kit

Device Class : 2

Duns Number: 803126320

Premarket Exempt : No

Product Code : PII

Prescription Use : Yes

Device Count : 1

T2Bacteria® QCheck Positive Kit - M70885071910 Catalog Number :

Device Description : Positive SK Control, Positive EPE Control

Device Class : 2

Duns Number: 803126320

Premarket Exempt : No

Product Code : QBX

Prescription Use : Yes

Device Count : 1

T2Bacteria® QCheck Negative Kit - M70885080743 Catalog Number :

Device Description : Negative Control for T2Bacteria Panel

Device Class :

Duns Number: 803126320

Premarket Exempt : No

Product Code : QBX

Prescription Use : Yes

Device Count : 8

T2Candida® QCheck Positive Kit - M70885083750 Catalog Number :

Device Description : Positive APG Control, Positive TPK Control

Device Class : 2

Duns Number: 803126320

Premarket Exempt : No

Product Code : PII

Prescription Use : Yes

Device Count : 1

T2Dx® QCheck Negative Kit - M70885083760 Catalog Number :

Device Description : Negative Control

Device Class : 2

Duns Number: 803126320

Premarket Exempt : No

Product Code : PII

Prescription Use : Yes

Device Count : 1

T2Dx® QCheck Negative Kit - M70885083763 Catalog Number :

Device Description : Negative Control

Device Class :

Duns Number: 803126320

Premarket Exempt : No

Product Code : PII

Prescription Use : Yes

Device Count : 8

T2Candida® Cartridge Kit - M70890017940 Catalog Number :

Device Description : The T2Candida components used to load the patient sample, contains disposables, The T2Candida components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.

Device Class : 2

Duns Number: 803126320

Premarket Exempt : No

Product Code : PII

Prescription Use : Yes

Device Count : 1

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