IgM IM3834

GUDID 05055273204001

For the quantitative in vitro determination of IgM in serum and plasma

RANDOX LABORATORIES LIMITED

Total immunoglobulin M (IgM total) IVD, antibody
Primary Device ID05055273204001
NIH Device Record Keycc55e1d5-ed9c-4888-a502-deb72230fcbc
Commercial Distribution StatusIn Commercial Distribution
Brand NameIgM
Version Model NumberIM3834
Catalog NumberIM3834
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
GS105055273204001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DFTIgm, 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 [IgM]

05055273204025For the quantitative in vitro determination of IgM in serum and plasma
05055273204001For the quantitative in vitro determination of IgM in serum and plasma

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