T2Bacteria® QCheck Negative Kit

Basic Information

• Brand Name: T2Bacteria® QCheck Negative Kit
• Primary DI: M70885080743
• Version / Model: 85-08074
• Company Name: T2 BIOSYSTEMS, INC.
• Labeler DUNS: 803126320
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 8
• Record Status: Published
• Publish Date: 2018-08-02
• Public Version: 4
• Public Version Date: 2024-02-21
• Public Version Status: Update
• Public Device Record Key: 1b258437-9d9f-45cb-b5d5-fd0968e65d54

Device Description

Negative Control for T2Bacteria Panel

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
63800	Multiple bloodstream bacteria nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from both multiple gram negative and gram positive bacterial species associated with bloodstream infection [e.g., Klebsiella pneumoniae, Escherichia coli (E. coli), Pseudomonas aeruginosa, Enterococcus faecium and Staphylococcus aureus) 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
Primary	M70885080743	HIBCC
Unit of Use	M70883080760	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K172708	000
K233184	000

Device Sizes

Type	Value	Unit	Text
Total Volume	4	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius