Poly Rb A-Hu IgM/HRP

GUDID 05700572007364

Polyclonal Rabbit Anti-Human IgM/HRP

Dako Denmark ApS

Total immunoglobulin M (IgM total) IVD, antibody
Primary Device ID05700572007364
NIH Device Record Key16a03288-6b3a-40b3-9d55-3338b8329a61
Commercial Distribution StatusIn Commercial Distribution
Brand NamePoly Rb A-Hu IgM/HRP
Version Model NumberP0215
Company DUNS305047466
Company NameDako Denmark ApS
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+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 Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 Milliliter
Total Volume2 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

Device Identifiers

Device Issuing AgencyDevice ID
GS105700572007364 [Primary]

FDA Product Code

DEYIGM, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-13
Device Publish Date2016-09-16

Devices Manufactured by Dako Denmark ApS

05700571106938 - FLEX Mono Rb A-Hu Cyclin D1, Cl EP12, RTU (Dako Omnis)2020-09-25 FLEX Monoclonal Rabbit Anti-Human Cyclin D1, Clone EP12, Ready-to-Use (Dako Omnis)
05700571107034 - FLEX Mono Mo A-Hu Mammaglobin Cl 304-1A5 RTU (Dako Omnis)2020-09-25 FLEX Monoclonal Mouse Anti-Human Mammaglobin Clone 304-1A5 Ready-to-Use (Dako Omnis)
05700571107041 - FLEX Mono Mo A-Hu Renal Cell Carcinoma Marker, Cl SPM314, RTU (Dako Omnis)2020-09-25 FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314, Ready-to-Use (Dako Omnis)
05700571107065 - FLEX Mono Mo A-Hu Caldesmon, Cl h-CD, RTU (Dako Omnis)2020-09-25 FLEX Monoclonal Mouse Anti-Human Caldesmon, Clone h-CD, Ready-to-Use (Dako Omnis)
05700571108451 - Artisan Link Pro2020-09-25 Artisan Link Pro
05700571112571 - Dako CoverStainer2020-09-25 Dako CoverStainer
05700572013693 - EasyLyse Erythrocyte-Lysing Reagent2020-09-25 EasyLyse Erythrocyte-Lysing Reagent
05700572000211 - Poly Rb A-Hu Prealbumin2020-09-25 Polyclonal Rabbit Anti-Human Prealbumin

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