HIV-1 Standard Test System

GUDID M769HIVSTANDARD211

The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to Home Access laboratory for testing.

Home Access Health Corporation

Capillary blood collection kit, home-use

• Primary Device ID: M769HIVSTANDARD211
• NIH Device Record Key: ae91c3c1-8168-454d-a853-a9def772088d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIV-1 Standard Test System
• Version Model Number: 21
• 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	M769HIVSTANDARD211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP950002

FDA Product Code

• MVZ: System,Test,Home,Hiv-1

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-11-23
• Device Publish Date: 2015-09-03

Devices Manufactured by Home Access Health Corporation

• M769HIVSTANDARD211 - HIV-1 Standard Test System: 2021-11-23The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to Home Access laboratory for testing.
• 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: 2020-07-07 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