IgG IG3896

GUDID 05055273203967

RANDOX LABORATORIES LIMITED

Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 05055273203967
• NIH Device Record Key: 39593eb2-00e0-47e9-859e-6a91b5b8c25c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IgG
• Version Model Number: IG3896
• Catalog Number: IG3896
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273203967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955798

FDA Product Code

• DEW: Igg, Antigen, Antiserum, Control

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-11
• Device Publish Date: 2019-06-03

On-Brand Devices [IgG]

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