AccessGUDID - DEVICE: T2Biothreat® Reagent Trays (M70880113943)

GUDID

Device Identifier (DI) Information

Brand Name: T2Biothreat® Reagent Trays
Version or Model: 80-11394
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: T2 BIOSYSTEMS, INC.

Primary DI Number: M70880113943
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 803126320 *Terms of Use

Device Description: The T2Biothreat Panel component that contains the assay reagent

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?
62711	Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials 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, using a nucleic acid technique (NAT). It is typically used to aid diagnosis incidences of suspected exposure to biological agents used in bioterrorism or biological warfare.	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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 93caf9d2-2a28-4dd0-81fe-37abe0c1dd92
Public Version Date: November 15, 2023
Public Version Number: 1
DI Record Publish Date: November 07, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: M70880113930 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (877) 504-8282
Email: t2service@t2biosystems.com

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