T2Biothreat® QCheck Negative Kit

GUDID M70883113970

Negative quality control for T2Biothreat Panel

T2 BIOSYSTEMS, INC.

Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
Primary Device IDM70883113970
NIH Device Record Key2b03caa2-b669-4fc5-8d9e-427b850a703c
Commercial Distribution StatusIn Commercial Distribution
Brand NameT2Biothreat® QCheck Negative Kit
Version Model Number85-11398
Company DUNS803126320
Company NameT2 BIOSYSTEMS, INC.
Device Count8
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com
Phone(877) 504-8282
Emailt2service@t2biosystems.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM70883113970 [Unit of Use]
HIBCCM70885113983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QVRMultiplex Nucleic Acid Detection System For Biothreat Agents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-15
Device Publish Date2023-11-07

Devices Manufactured by T2 BIOSYSTEMS, INC.

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M70880080720 - T2Bacteria® Reagent Trays2024-02-28 The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria Panel.
M70885080730 - T2Bacteria® QCheck Positive Kit2024-02-28 Positive ASK Control, Positive EPE Control
M70885080743 - T2Bacteria® QCheck Negative Kit 2024-02-16 Negative Control for T2Bacteria Panel
M70880113930 - T2Biothreat® Reagent Trays2023-11-15 The T2Biothreat Panel component that contains the assay reagent
M70883113950 - T2Biothreat® QCheck Positive Kit 2023-11-15 Buffer based solution with containing non-pathogenic bacterial strains with the T2Biothreat Panel target sequences.
M70883113970 - T2Biothreat® QCheck Negative Kit2023-11-15Negative quality control for T2Biothreat Panel
M70883113970 - T2Biothreat® QCheck Negative Kit2023-11-15 Negative quality control for T2Biothreat Panel
M70870049330 - T2Dx®2022-09-16 Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top ho

Trademark Results [T2Biothreat]

Mark Image

Registration | Serial
Company
Trademark
Application Date
T2BIOTHREAT
T2BIOTHREAT
88872606 not registered Live/Pending
T2 Biosystems, Inc.
2020-04-15

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