IgG IG3833

GUDID 05055273203950

The IgG test system is a device intended for the quantitative in vitro determination of immunoglobulin G (IgG) concentration in serum and plasma

RANDOX LABORATORIES LIMITED

Total immunoglobulin G (IgG total) IVD, antibody
Primary Device ID05055273203950
NIH Device Record Key63d0666b-032a-4180-a4e7-00bcd5b01fe5
Commercial Distribution StatusIn Commercial Distribution
Brand NameIgG
Version Model NumberIG3833
Catalog NumberIG3833
Company DUNS227530649
Company NameRANDOX LABORATORIES LIMITED
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 Usetrue
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+442894451070
Emailtechnical.services@randox.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273203950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DEWIgg, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [IgG]

05055273203974The IgG test system is a device intended for the quantitative in vitro determination of immunogl
05055273203950The IgG test system is a device intended for the quantitative in vitro determination of immunogl
05055273203936The IgG test system is a device intended for the quantitative in vitro determination of immunogl
05055273203967IG3896

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