Artisan Link Pro - Artisan Link Pro - AGILENT TECHNOLOGIES SINGAPORE PTE LTD

Duns Number:894671143

Device Description: Artisan Link Pro

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More Product Details

Catalog Number

-

Brand Name

Artisan Link Pro

Version/Model Number

AR310

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KPA

Product Code Name

Slide stainer, automated

Device Record Status

Public Device Record Key

e81f0d75-09ce-43ab-853f-f0494b6a3ba7

Public Version Date

December 07, 2020

Public Version Number

2

DI Record Publish Date

September 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AGILENT TECHNOLOGIES SINGAPORE PTE LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 490
2 A medical device with a moderate to high risk that requires special controls. 43
3 A medical device with high risk that requires premarket approval 5