Catalog Number

-

Brand Name

URiSCAN 1 Ketones strip

Version/Model Number

U151

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

K952307

Product Code

JIN

Product Code Name

Nitroprusside, Ketones (Urinary, Non-Quant.)

Public Device Record Key

20a08855-562f-44f8-9cb7-d1e32ee4183d

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

November 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-