Artisan User Fillable Dispenser #1

GUDID 05700571101032

Artisan User Fillable Dispenser #1

Dako North America, Inc.

Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use
Primary Device ID05700571101032
NIH Device Record Keye09e8ebb-20a3-4d03-87c1-0f9432605599
Commercial Distribution StatusIn Commercial Distribution
Brand NameArtisan User Fillable Dispenser #1
Version Model NumberAR185
Company DUNS099999732
Company NameDako North America, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com
Phone+1-805-566-6655
Emaildako.usregulatory@agilent.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105700571101032 [Primary]

FDA Product Code

KPASlide stainer, automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-25
Device Publish Date2020-09-17

Devices Manufactured by Dako North America, Inc.

05700571011539 - FLEX Mono Mo A-Hu E-Cadherin Cl NCH-38 RTU2020-09-25 FLEX Monoclonal Mouse Anti-Human E-Cadherin Clone NCH-38 Ready-to-Use (Dako Autostainer/ Autostainer Plus)
05700571100738 - Artisan Alpha Amylase2020-09-25 Artisan Alpha Amylase
05700571100745 - Artisan Alpha Amylase2020-09-25 Artisan Alpha Amylase
05700571101032 - Artisan User Fillable Dispenser #12020-09-25Artisan User Fillable Dispenser #1
05700571101032 - Artisan User Fillable Dispenser #12020-09-25 Artisan User Fillable Dispenser #1
05700571101186 - FLEX Poly Guinea Pig A-Insulin RTU (Link)2020-09-25 FLEX Polyclonal Guinea Pig Anti-Insulin Ready-to-Use (Link)
05700571101193 - FLEX Mono Mo A-Hu Smooth Muscle Myosin Heavy Chain Cl SMMS-1 RTU (Link)2020-09-25 FLEX Monoclonal Mouse Anti-Human Smooth Muscle Myosin Heavy Chain Clone SMMS-1 Ready-to-Use (Link)
05700571101209 - FLEX Mono Mo A-Myogenin Cl F5D RTU (Link)2020-09-25 FLEX Monoclonal Mouse Anti-Myogenin Clone F5D Ready-to-Use (Link)
05700571101216 - FLEX Mono Mo A-Hu CD1a Cl 010 RTU (Link)2020-09-25 FLEX Monoclonal Mouse Anti-Human CD1a Clone 010 Ready-to-Use (Link)

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