Catalog Number

110608

Brand Name

HemoCue® Urine Albumin Microcuvettes

Version/Model Number

110608

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KQO

Product Code Name

Automated Urinalysis System

Public Device Record Key

140798c8-4077-4476-b72b-b32e4dbecd56

Public Version Date

May 03, 2019

Public Version Number

1

DI Record Publish Date

April 25, 2019

Package DI Number

27311091106081

Quantity per Package

25

Contains DI Package

17311091106084

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package