Express HIV-1 Test System

GUDID M769HIVEXPRESS201

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 a qualified laboratory for testing.

Home Access Health Corporation

Home blood collection kit Home blood collection kit Home blood collection kit Home blood collection kit Home blood collection kit Home blood collection kit Home blood collection kit Home blood collection kit Home blood collection kit Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use Capillary blood collection kit, home-use
Primary Device IDM769HIVEXPRESS201
NIH Device Record Key74914157-a27c-4b4e-b8cd-f60b12da3d0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameExpress HIV-1 Test System
Version Model Number20
Company DUNS848511283
Company NameHome Access Health Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com
Phone847-781-2503
Emailmvogt@homeaccess.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM769HIVEXPRESS201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVZSystem,Test,Home,Hiv-1

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-07
Device Publish Date2015-09-03

Devices Manufactured by Home Access Health Corporation

M769HIVSTANDARD211 - HIV-1 Standard Test System2021-11-23 The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibod
M769FITCHEK351 - FIT-CHEK2021-04-21 Fecal Immunochemical Test to screen for Colorectal Cancer.
M769FITCHEK361 - FIT-CHEK2021-04-21 Fecal Immunochemical Test to screen for Colorectal Cancer.
M769A1C821 - HOME ACCESS A1C TEST2020-07-07 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 TEST2020-07-07 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 PANEL2020-07-07 Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used i
M769CHOLESTEROL811 - CHECK UP AMERICAL CHOLESTEROL PANEL2020-07-07 Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used i
M769HCV271 - Hepatitis C Check2020-07-07 The Home Access Health Corporation Hepatitis C Check Test System is intended for use by persons to determine if antibodies to HC
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.