Catalog Number

11895460160

Brand Name

Chemstrip 2 LN Test Strips

Version/Model Number

11895460160

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

LJX

Product Code Name

TEST, URINE LEUKOCYTE

Public Device Record Key

b3349a4c-8a2d-4d38-bd0f-a3f3065a59c6

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

January 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-