Catalog Number

87329E

Brand Name

KOVA

Version/Model Number

87329E

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

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

K843565

Product Code

JJW

Product Code Name

Urinalysis Controls (Assayed And Unassayed)

Public Device Record Key

ad9998a9-ca6b-477e-bddd-dd7ba2cacc5e

Public Version Date

August 07, 2020

Public Version Number

1

DI Record Publish Date

July 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-