HER2 CISH pharmDx™ Kit

GUDID 05700572032960

HER2 CISH pharmDx Kit

Dako Denmark ApS

Her2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT)
Primary Device ID05700572032960
NIH Device Record Key23700536-ef99-466a-8e1c-73d88d501d4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHER2 CISH pharmDx™ Kit
Version Model NumberSK109
Company DUNS305047466
Company NameDako Denmark ApS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com
Phone+4544859500
Emaildako.dkregulatory@agilent.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in the dark

Device Identifiers

Device Issuing AgencyDevice ID
GS105700572032960 [Primary]

FDA Product Code

NYQChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-13
Device Publish Date2014-09-15

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