Catalog Number

-

Brand Name

Tyson Bio HT100 Control Solution Level 1

Version/Model Number

HT100

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170079,K170079,K170079

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

147d0d72-e853-4688-be77-df6aa694df6f

Public Version Date

August 10, 2020

Public Version Number

2

DI Record Publish Date

July 17, 2018

Package DI Number

14719869701937

Quantity per Package

50

Contains DI Package

04719869701930

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-