User-Fillable Reagent Bottle 5mL Capacity (Link)

GUDID 05700571112465

User-Fillable Reagent Bottle 5mL Capacity (Link)

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
Primary Device ID05700571112465
NIH Device Record Keye44d4ecd-dce8-41ba-be7c-53cb6a30b242
Commercial Distribution StatusIn Commercial Distribution
Brand NameUser-Fillable Reagent Bottle 5mL Capacity (Link)
Version Model NumberSK200
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

Device Dimensions

Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105700571104842 [Primary]
GS105700571112465 [Package]
Contains: 05700571104842
Package: Box [25 Units]
In Commercial Distribution

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

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