Catalog Number

-

Brand Name

Thermo Scientific Infinity™ for Beckman Coulter AU® Chemistry Analyzers

Version/Model Number

106517

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

K003583,K003583

Product Code

NDW

Product Code Name

Assay, Porphyrin, Spectrophotometry, Lithium

Public Device Record Key

40d27ea0-1c4c-409c-b062-cb3b18da33f7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-