Catalog Number

01R3565

Brand Name

Alinity

Version/Model Number

01R3565

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MZA

Product Code Name

Test, equipment, automated bloodborne pathogen

Public Device Record Key

8dadf8a7-c280-4a56-b3a6-5a1d9991cbf7

Public Version Date

October 10, 2022

Public Version Number

3

DI Record Publish Date

July 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-