Catalog Number

6860515

Brand Name

ADVIA® Chemistry CRE_2c Creatinine Reagents, Concentrated

Version/Model Number

10283346

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K991576

Product Code

CGX

Product Code Name

ALKALINE PICRATE, COLORIMETRY, CREATININE

Public Device Record Key

6d61837b-4fa1-4101-a4ab-8dc3fc2cd83e

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-