CHECK UP AMERICA CHOLESTEROL PANEL

GUDID M769CHOLESTEROL801

Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood.

Home Access Health Corporation

Home blood collection kit

• Primary Device ID: M769CHOLESTEROL801
• NIH Device Record Key: 2e491e8f-3c11-44e5-b13d-7b4a34133b78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHECK UP AMERICA CHOLESTEROL PANEL
• Version Model Number: 80
• Company DUNS: 848511283
• Company Name: Home Access Health 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M769CHOLESTEROL801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063852

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: 2020-07-07
• Device Publish Date: 2016-09-09

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