Catalog Number

800-7005

Brand Name

iChem

Version/Model Number

iChem®10SG Urine Chemistry Strips

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

47ab9987-b82e-484b-95d5-0d61584d8eb6

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

September 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-