CHOLESTEROL (CHOL)

GUDID 05055273208443

RANDOX LABORATORIES LIMITED

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• Primary Device ID: 05055273208443
• NIH Device Record Key: ed0ce9b0-992c-4da3-aac5-7fee4dd1a53d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHOLESTEROL (CHOL)
• Version Model Number: CH8019
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	05055273208443 [Primary]

FDA Product Code

• CHH: Enzymatic Esterase--Oxidase, Cholesterol

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 [CHOLESTEROL (CHOL)]

• 05055273208443: CH8019
• 05055273208474: For the quantitative in vitro determination of cholesterol in serum and plasma.
• 05055273201130: For the quantitative in vitro determination of Cholesterol in serum and plasma.