AccessGUDID - DEVICE: T2Bacteria® QCheck Negative Kit (M70885080743)

GUDID

Device Identifier (DI) Information

Brand Name: T2Bacteria® QCheck Negative Kit
Version or Model: 85-08074
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: T2 BIOSYSTEMS, INC.

Primary DI Number: M70885080743
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 8
Labeler D-U-N-S® Number*: 803126320 *Terms of Use

Device Description: Negative Control for T2Bacteria Panel

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QBX	Direct Blood Bacterial Nucleic Acid Detection System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172708	000
K233184	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 4 Milliliter

Device Record Status

Public Device Record Key: 1b258437-9d9f-45cb-b5d5-fd0968e65d54
Public Version Date: February 21, 2024
Public Version Number: 4
DI Record Publish Date: August 02, 2018