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 ID: 05055273204001
• NIH Device Record Key: cc55e1d5-ed9c-4888-a502-deb72230fcbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IgM
• Version Model Number: IM3834
• Catalog Number: IM3834
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273204001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955797

FDA Product Code

• DFT: Igm, Antigen, Antiserum, Control

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [IgM]

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