T2Biothreat® Reagent Trays

GUDID M70880113930

Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Primary Device ID	M70880113930
NIH Device Record Key	93caf9d2-2a28-4dd0-81fe-37abe0c1dd92
Commercial Distribution Status	In Commercial Distribution
Brand Name	T2Biothreat® Reagent Trays
Version Model Number	80-11394
Company DUNS	803126320
Company Name	T2 BIOSYSTEMS, INC.
Device Count	12
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	M70880113930 [Unit of Use]
HIBCC	M70880113943 [Primary]

QVR	Multiplex Nucleic Acid Detection System For Biothreat Agents

Steralize Prior To Use	false
Device Is Sterile	false

M70880016893 - T2Candida® Reagent Trays	2024-09-19 The T2Candida component that contains the refrigerated reagents used to perform the T2Candida panel.
M70880080720 - T2Bacteria® Reagent Trays	2024-02-28 The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria Panel.
M70885080730 - T2Bacteria® QCheck Positive Kit	2024-02-28 Positive ASK Control, Positive EPE Control
M70885080743 - T2Bacteria® QCheck Negative Kit	2024-02-16 Negative Control for T2Bacteria Panel
M70880113930 - T2Biothreat® Reagent Trays	2023-11-15The T2Biothreat Panel component that contains the assay reagent
M70880113930 - T2Biothreat® Reagent Trays	2023-11-15 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 Kit	2023-11-15 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

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