KOVA - KOVA-TROL III Normal (8X60mL) - KOVA INTERNATIONAL, INC.

Duns Number:078780990

Device Description: KOVA-TROL III Normal (8X60mL)

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More Product Details

Catalog Number

87528

Brand Name

KOVA

Version/Model Number

87528

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

JJW

Product Code Name

Urinalysis Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

a3fe4269-cd24-4d76-a88c-15b190e00516

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

July 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOVA INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 114