Catalog Number

-

Brand Name

T2Bacteria® QCheck Negative Kit

Version/Model Number

85-08074

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

K172708,K172708

Product Code

QBX

Product Code Name

Direct Blood Bacterial Nucleic Acid Detection System

Public Device Record Key

1b258437-9d9f-45cb-b5d5-fd0968e65d54

Public Version Date

October 30, 2018

Public Version Number

2

DI Record Publish Date

August 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-