LipidPlus® Total Cholesterol Test Strips

GUDID 10763924532107

Lipid and Glucose Measuring System

JANT PHARMACAL CORPORATION

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• Primary Device ID: 10763924532107
• NIH Device Record Key: bf0bce25-636a-4131-aa61-68616b49360a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LipidPlus® Total Cholesterol Test Strips
• Version Model Number: MD532
• Company DUNS: 797393659
• Company Name: JANT PHARMACAL CORPORATION
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: true

Device Dimensions

• Total Volume: 5 Microliter
• Total Volume: 5 Microliter
• Total Volume: 5 Microliter
• Total Volume: 5 Microliter
• Total Volume: 5 Microliter
• Total Volume: 5 Microliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10763924532107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130295

FDA Product Code

• CHH: Enzymatic Esterase--Oxidase, Cholesterol

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2017-02-16

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