Poly Rb A-Hu IgM

GUDID 05700572001416

Polyclonal Rabbit Anti-Human IgM

Dako Denmark ApS

Total immunoglobulin M (IgM total) IVD, antibody
Primary Device ID05700572001416
NIH Device Record Key92bf4953-0e09-4422-bfb8-2ff447e61871
Commercial Distribution StatusIn Commercial Distribution
Brand NamePoly Rb A-Hu IgM
Version Model NumberA0426
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 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
GS105700572001416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DAOIGM (MU CHAIN SPECIFIC), ANTIGEN, ANTISERUM, CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-03-13
Device Publish Date2016-09-16

On-Brand Devices [Poly Rb A-Hu IgM]

05700572001416Polyclonal Rabbit Anti-Human IgM
05700572001409Polyclonal Rabbit Anti-Human IgM

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