Catalog Number

11895362160

Brand Name

CHEMSTRIP 2 GP URINE TEST STRIPS

Version/Model Number

11895362160

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

K896454

Product Code

JIL

Product Code Name

METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Public Device Record Key

65eec64d-4b1b-4be7-b555-2835b25199ef

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-