Catalog Number

HU982-1250

Brand Name

Pointe Scientific, Inc. Uric Acid

Version/Model Number

HU982-1250

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

K970560

Product Code

KNK

Product Code Name

Acid, Uric, Uricase (Colorimetric)

Public Device Record Key

fe7b818d-5fb5-4bc2-80df-8beb397a77c0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-