Catalog Number

09N19-012

Brand Name

Alinity m

Version/Model Number

09N19-012

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

K202977,K202977,K202977

Product Code

LSL

Product Code Name

DNA-REAGENTS, NEISSERIA

Public Device Record Key

b2a36e8b-60de-4c4a-94ea-a8f74a105c13

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

Package DI Number

30884999050410

Quantity per Package

10

Contains DI Package

20884999050413

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case