Catalog Number

11775685216

Brand Name

Creatinine Plus

Version/Model Number

11775685216

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 11, 2018

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

K812095

Product Code

JFY

Product Code Name

ENZYMATIC METHOD, CREATININE

Public Device Record Key

40af038a-cb37-434f-8f1b-8b094c61df9c

Public Version Date

November 03, 2020

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

-