AccessGUDID - DEVICE: T2Candida® QCheck Positive Kit (M70885083750)

GUDID

Device Identifier (DI) Information

Brand Name: T2Candida® QCheck Positive Kit
Version or Model: 85-08375
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: T2 BIOSYSTEMS, INC.

Primary DI Number: M70885083750
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 803126320 *Terms of Use

Device Description: Positive APG Control, Positive TPK Control

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:	Yes
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?
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.	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 -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 4 Milliliter

Device Record Status

Public Device Record Key: ad1f0905-ec7f-40c0-b099-2819d6da2a4c
Public Version Date: July 26, 2018
Public Version Number: 1
DI Record Publish Date: June 25, 2018

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: No Unit of Use DI Numbers Found 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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES