Catalog Number

06P1601

Brand Name

Alinity

Version/Model Number

06P1601

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

8e753c0f-f42b-4fc3-a1f3-d4289124c94f

Public Version Date

October 17, 2022

Public Version Number

8

DI Record Publish Date

July 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-