Catalog Number

87222E

Brand Name

KOVA

Version/Model Number

87222E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 12, 2020

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JJW

Product Code Name

Urinalysis Controls (Assayed And Unassayed)

Public Device Record Key

91942ac7-609b-4410-8930-d9bd8aea0ba1

Public Version Date

August 13, 2020

Public Version Number

2

DI Record Publish Date

July 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-