CHECK UP AMERICAL CHOLESTEROL PANEL

GUDID M769CHOLESTEROL811

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: M769CHOLESTEROL811
• NIH Device Record Key: 6029b62f-c762-46d9-be9b-336d55d99cf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHECK UP AMERICAL CHOLESTEROL PANEL
• Version Model Number: 81
• 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	M769CHOLESTEROL811 [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

Devices Manufactured by Home Access Health Corporation

• M769HIVSTANDARD211 - HIV-1 Standard Test System: 2021-11-23 The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibod
• M769FITCHEK351 - FIT-CHEK: 2021-04-21 Fecal Immunochemical Test to screen for Colorectal Cancer.
• M769FITCHEK361 - FIT-CHEK: 2021-04-21 Fecal Immunochemical Test to screen for Colorectal Cancer.
• M769A1C821 - HOME ACCESS A1C TEST: 2020-07-07 The Home Access A1c Test kit is an in vitro test for the quantitative measurement of Hemoglobin A1c using capillary blood. Meas
• M769A1CPCP841 - HOME ACCESS A1C TEST: 2020-07-07 The Home Access A1c Test kit is an in vitro test for the quantitative measurement of Hemoglobin A1c using capillary blood. Meas
• M769CHOLESTEROL801 - CHECK UP AMERICA CHOLESTEROL PANEL: 2020-07-07 Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used i
• M769CHOLESTEROL811 - CHECK UP AMERICAL CHOLESTEROL PANEL: 2020-07-07Cholesterol 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.
• M769CHOLESTEROL811 - CHECK UP AMERICAL CHOLESTEROL PANEL: 2020-07-07 Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used i
• M769HCV271 - Hepatitis C Check: 2020-07-07 The Home Access Health Corporation Hepatitis C Check Test System is intended for use by persons to determine if antibodies to HC