Catalog Number

HB952-1020

Brand Name

Pointe Scientific, Inc.

Version/Model Number

HB952-1020

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

K972671

Product Code

CDQ

Product Code Name

Urease And Glutamic Dehydrogenase, Urea Nitrogen

Public Device Record Key

e8562cac-121f-44ec-acbc-57a40a419823

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-