Catalog Number

10020

Brand Name

Unyvero

Version/Model Number

M1 Master Mix Tube Kit

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

DEN170047

Product Code

QBH

Product Code Name

Lower respiratory microbial nucleic acid detection system

Public Device Record Key

9b301b58-8344-4835-af1d-498942e7622d

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-