AccessGUDID - DEVICE: T2Biothreat® QCheck Negative Kit (M70885113983)

GUDID

Device Identifier (DI) Information

Brand Name: T2Biothreat® QCheck Negative Kit
Version or Model: 85-11398
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: T2 BIOSYSTEMS, INC.

Primary DI Number: M70885113983
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 8
Labeler D-U-N-S® Number*: 803126320 *Terms of Use

Device Description: Negative quality control for T2Biothreat 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?
66859	Multiple-type biothreat/febrile infection-associated pathogen 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 acid from multiple types of microorganisms (e.g., bacteria and viruses such as Bacillus anthracis, Francisella tularensis, Yersinia pestis, Ebola virus, influenza A virus) associated with biothreat/febrile infection in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QVR	Multiplex Nucleic Acid Detection System For Biothreat Agents
QBX	Direct Blood Bacterial Nucleic Acid Detection System
NSU	Instrumentation For Clinical Multiplex Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231336	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
No Device Sizes

Device Record Status

Public Device Record Key: 2b03caa2-b669-4fc5-8d9e-427b850a703c
Public Version Date: November 15, 2023
Public Version Number: 1
DI Record Publish Date: November 07, 2023