Catalog Number

-

Brand Name

Cystatin C Control Set

Version/Model Number

X0973

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 10, 2019

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

-

Product Code

JIT

Product Code Name

CALIBRATOR, SECONDARY

Public Device Record Key

f205e456-b0f6-4e7e-a8d9-f7fd83297826

Public Version Date

December 07, 2020

Public Version Number

7

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-