Catalog Number

KAI-302C

Brand Name

K-ASSAY® UIBC Calibrator

Version/Model Number

KAI-302C

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JMO

Product Code Name

Ferrozine (Colorimetric) Iron Binding Capacity

Public Device Record Key

2318ea39-aa3b-41d5-b145-0c1d91ee72b0

Public Version Date

April 17, 2019

Public Version Number

1

DI Record Publish Date

April 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-