Catalog Number

-

Brand Name

Urine Reagent Strips, 1-parameter, blood

Version/Model Number

URS-01PR-BL77

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

K023297

Product Code

JIO

Product Code Name

Blood, Occult, Colorimetric, In Urine

Public Device Record Key

8c676b34-cd67-403d-a578-0f0b3ec240b0

Public Version Date

October 07, 2019

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

-