Catalog Number

-

Brand Name

Areta pH Urinalysis Reagent Strips (100 tests kit）

Version/Model Number

U031-013

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

-

Product Code

CDM

Product Code Name

Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

Public Device Record Key

fd3a8877-a845-494a-b434-75deefc15cf5

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

August 05, 2016

Package DI Number

00850253007031

Quantity per Package

1

Contains DI Package

00850253007024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-