Catalog Number

09N26-001

Brand Name

Alinity m

Version/Model Number

09N26-001

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OOI

Product Code Name

real time Nucleic acid amplification system

Public Device Record Key

eb8ec454-d148-45b9-ac37-e4ad4c8ebd6b

Public Version Date

September 02, 2022

Public Version Number

4

DI Record Publish Date

April 29, 2020

Package DI Number

20884999047840

Quantity per Package

12

Contains DI Package

00884999047846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case