T2 BIOSYSTEMS, INC.

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

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Filters

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) (1) Direct Blood Bacterial Nucleic Acid Detection System (QBX) (1)

Premarket Exempt

Clear

T2Candida® 1.1 Cartridge Kit - M70890078170 Catalog Number :

Device Description : The T2Candida 1.1 Cartridge components used to load the patient sample, contains The T2Candida 1.1 Cartridge 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

T2Bacteria® Cartridge Kit - M70890080710 Catalog Number :

Device Description : The T2Bacteria Cartridge components used to load the patient sample, contains di The T2Bacteria Cartridge components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Bacteria panel.

Device Class : 2

Duns Number: 803126320

Premarket Exempt : No

Product Code : QBX

Prescription Use : Yes

Device Count : 1

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