DIRECT LDL-CHOLESTEROL (LDL)

GUDID 05055273208498

RANDOX LABORATORIES LIMITED

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• Primary Device ID: 05055273208498
• NIH Device Record Key: c814714f-9a3d-42d1-aaa3-146a5b093499
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIRECT LDL-CHOLESTEROL (LDL)
• Version Model Number: CH8312
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273208498 [Primary]

FDA Product Code

• MRR: System, Test, Low Density, Lipoprotein

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 [DIRECT LDL-CHOLESTEROL (LDL)]

• 05055273208498: CH8312
• 05055273208450: CH8032
• 05055273213966: Enzymatic Clearance assay for the in vitro quantitative determination of LDL-cholesterol in huma