Catalog Number

4851534

Brand Name

ADVIA® Chemistry CYSC Cystatin-C Reagents

Version/Model Number

10361930

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 03, 2022

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

K083906

Product Code

NDY

Product Code Name

TEST, CYSTATIN C

Public Device Record Key

5dabbb6a-db9d-4235-8a8c-63656d55e2f6

Public Version Date

March 07, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-