Catalog Number

120623

Brand Name

HemoCue® Albumin 201 Analyzer

Version/Model Number

120623

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

-

Product Code

KQO

Product Code Name

Automated Urinalysis System

Public Device Record Key

e78eba27-1836-4512-bef9-be4294cff29d

Public Version Date

May 03, 2019

Public Version Number

1

DI Record Publish Date

April 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-