T2Dx® QCheck Negative Kit

GUDID M70885083760

Negative Control

T2 BIOSYSTEMS, INC.

Multiple Candida species nucleic acid IVD, control
Primary Device IDM70885083760
NIH Device Record Keyd3c8d86c-a395-4922-ad04-e118f04db99f
Commercial Distribution Discontinuation2020-02-18
Commercial Distribution StatusNot in Commercial Distribution
Brand NameT2Dx® QCheck Negative Kit
Version Model Number85-08376
Company DUNS803126320
Company NameT2 BIOSYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-504-8282
Emailt2service@t2biosystems.com

Device Dimensions

Total Volume4 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM70885083760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PIICandida Species Nucleic Acid Detection System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-19
Device Publish Date2018-06-25

On-Brand Devices [T2Dx® QCheck Negative Kit ]

M70885083760Negative Control
M70885083763Negative Control

Trademark Results [T2Dx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
T2DX
T2DX
77521306 4142915 Live/Registered
T2 BIOSYSTEMS, INC.
2008-07-14

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