T2Candida® Cartridge Kit

GUDID M70890017940

The T2Candida components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.

T2 BIOSYSTEMS, INC.

Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent Multiple Candida species nucleic acid IVD, reagent

• Primary Device ID: M70890017940
• NIH Device Record Key: f55b13d5-814e-4e8a-83e1-3e90961c55d9
• Commercial Distribution Discontinuation: 2018-09-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: T2Candida® Cartridge Kit
• Version Model Number: 90-01794
• Company DUNS: 803126320
• Company Name: T2 BIOSYSTEMS, INC.
• Device Count: 1
• 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
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M70890017940 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-28
• Device Publish Date: 2017-02-12

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• M70890017940 - T2Candida® Cartridge Kit: 2022-04-28The T2Candida components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.
• M70890017940 - T2Candida® Cartridge Kit: 2022-04-28 The T2Candida components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida p