T2Dx® QCheck Negative Kit

GUDID M70885083763

Negative Control

T2 BIOSYSTEMS, INC.

Multiple Candida species nucleic acid IVD, control

• Primary Device ID: M70885083763
• NIH Device Record Key: 1f2b9f62-5067-4a96-a216-5399e527448e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2Dx® QCheck Negative Kit
• Version Model Number: 85-08376
• Company DUNS: 803126320
• Company Name: T2 BIOSYSTEMS, INC.
• Device Count: 8
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: 877-504-8282
• Email: t2service@t2biosystems.com

Device Dimensions

• Total Volume: 4 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M70883083580 [Unit of Use]
HIBCC	M70885083760 [Previous]
HIBCC	M70885083763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN140019

FDA Product Code

• PII: Candida Species Nucleic Acid Detection System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-26
• Device Publish Date: 2020-02-18

On-Brand Devices [T2Dx® QCheck Negative Kit ]

• M70885083760: Negative Control
• M70885083763: Negative Control