T2Bacteria® Reagent Trays

Basic Information

• Brand Name: T2Bacteria® Reagent Trays
• Primary DI: M70880080723
• Version / Model: 80-08072
• Company Name: T2 BIOSYSTEMS, INC.
• Labeler DUNS: 803126320
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2024-02-20
• Public Version: 1
• Public Version Date: 2024-02-28
• Public Version Status: New
• Public Device Record Key: 6a101fa6-247d-4a85-ba48-8c7c8a9bef65

Device Description

The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria Panel.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QBX	Direct Blood Bacterial Nucleic Acid Detection System	Microbiology	866.3960	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61312	Multiple-type bloodstream pathogen nucleic acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorganisms associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	M70880080720	HIBCC
Primary	M70880080723	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K172708	000
K233184	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius