Catalog Number

05200881001

Brand Name

cobas z 480

Version/Model Number

05200881001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 02, 2018

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

LSL

Product Code Name

DNA-REAGENTS, NEISSERIA

Public Device Record Key

37c13be6-1f8d-4d5a-a56e-ff629700e425

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

September 15, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-