Catalog Number

-

Brand Name

Urine Reagent Strips, 2-parameter; glucose, protein

Version/Model Number

URS-02PR-GLPR

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K955438

Product Code

JIL

Product Code Name

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Public Device Record Key

747414c9-9b5a-4fd0-934e-49b64d482bb5

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-