Catalog Number

-

Brand Name

T2Dx® QCheck Negative Kit

Version/Model Number

85-08376

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 18, 2020

Issuing Agency

In HIBCC

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

DEN140019

Product Code

PII

Product Code Name

Candida Species Nucleic Acid Detection System

Public Device Record Key

d3c8d86c-a395-4922-ad04-e118f04db99f

Public Version Date

February 19, 2020

Public Version Number

2

DI Record Publish Date

June 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-