Catalog Number

-

Brand Name

T2Candida® QCheck Positive Kit

Version/Model Number

85-08375

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

ad1f0905-ec7f-40c0-b099-2819d6da2a4c

Public Version Date

July 26, 2018

Public Version Number

1

DI Record Publish Date

June 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-