T2Candida® External Controls

Basic Information

• Brand Name: T2Candida® External Controls
• Primary DI: M70885049190
• Version / Model: 85-04919
• Company Name: T2 BIOSYSTEMS, INC.
• Labeler DUNS: 803126320
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-12
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1d7ede18-1c79-4eae-b85b-d13e30dcc41c

Device Description

IVD Positive APG, Positive TPK, Negative EDTA Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PII	Candida Species Nucleic Acid Detection System	Microbiology	866.3960	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52030	Multiple Candida species 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 one or 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M70885049190	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN140019	000

Device Sizes

Type	Value	Unit	Text
Total Volume	4	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -22 – -18 Degrees Celsius