Poly Rb A-Hu Fibrinogen

GUDID 05700572000556

Polyclonal Rabbit Anti-Human Fibrinogen

Dako Denmark ApS

Fibrinogen (Factor I) assay IVD, antibody
Primary Device ID05700572000556
NIH Device Record Keyb39b4090-470c-4747-94a2-8b2865b9f4b1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePoly Rb A-Hu Fibrinogen
Version Model NumberA0080
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
GS105700572000556 [Primary]

FDA Product Code

DAZFIBRINOGEN AND SPLIT PRODUCTS, 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

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05700572013693 - EasyLyse Erythrocyte-Lysing Reagent2020-09-25 EasyLyse Erythrocyte-Lysing Reagent
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