FLEX Mono Rb A-Hu Estrogen Receptor a, Cl EP1, RTU (Dako Omnis)

GUDID 05700571108147

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis)

Dako Denmark ApS

Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody Estrogen (oestrogen)/progesterone receptor IVD, antibody
Primary Device ID05700571108147
NIH Device Record Key055c2068-c8d5-4817-8203-a1ec404bc753
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLEX Mono Rb A-Hu Estrogen Receptor a, Cl EP1, RTU (Dako Omnis)
Version Model NumberGA084
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 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 Perscriptiontrue
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
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

Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 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

Device Identifiers

Device Issuing AgencyDevice ID
GS105700571108147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYAIMMUNOHISTOCHEMISTRY ANTIBODY ASSAY, ESTROGEN RECEPTOR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-13
Device Publish Date2018-03-01

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