AccessGUDID - DEVICE: T2Candida® Reagent Trays (M70880016893)

GUDID

Device Identifier (DI) Information

Brand Name: T2Candida® Reagent Trays
Version or Model: 80-01689
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: T2 BIOSYSTEMS, INC.

Primary DI Number: M70880016893
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 803126320 *Terms of Use

Device Description: The T2Candida component that contains the refrigerated reagents used to perform the T2Candida 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?
52031	Multiple Candida species nucleic acid IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from multiple species of the yeast Candida in a clinical specimen. Candida species intended to be detected may include Candida albicans, Candida dubliniensis, Candida glabrata, Candida kefyr, Candida krusei, Candida parapsilosis and/or Candida tropicalis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PII	Candida Species Nucleic Acid Detection System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN140019	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: d3bc7271-de7f-4233-bbd2-29de4ae036a3
Public Version Date: September 19, 2024
Public Version Number: 4
DI Record Publish Date: February 12, 2017