AccessGUDID - DEVICE: T2Bacteria® Reagent Trays (M70880080723)

GUDID

Device Identifier (DI) Information

Brand Name: T2Bacteria® Reagent Trays
Version or Model: 80-08072
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: T2 BIOSYSTEMS, INC.

Primary DI Number: M70880080723
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 803126320 *Terms of Use

Device Description: The T2Bacteria component that contains the refrigerated reagents used to perform the 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:	No
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?
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.	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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6a101fa6-247d-4a85-ba48-8c7c8a9bef65
Public Version Date: February 28, 2024
Public Version Number: 1
DI Record Publish Date: February 20, 2024