FDA.reportPublic FDA data

Express HIV-1 Test System

Primary DI
M769HIVEXPRESS201
Brand
Express HIV-1 Test System
Company
Home Access Health Corporation
Model
20
Device description
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.
Published
2015-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVZSystem,Test,Home,Hiv-1

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVZSystem, Test, Home, Hiv-1Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BP9500020

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BP9500020

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M769HIVEXPRESS201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Home blood collection kitA collection of devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
847-781-2503mvogt@homeaccess.com

Regulatory Flags#

DUNS number
848511283
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M769HIVSTANDARD211HIV-1 Standard Test System212015-09-03
M769A1C821HOME ACCESS A1C TEST822016-09-09
M769A1CPCP841HOME ACCESS A1C TEST842017-10-06
M769CHOLESTEROL801CHECK UP AMERICA CHOLESTEROL PANEL802016-09-09
M769CHOLESTEROL811CHECK UP AMERICAL CHOLESTEROL PANEL812016-09-09
M769HCV271Hepatitis C Check272015-09-03
M769FITCHEK351FIT-CHEK352016-09-09
M769FITCHEK361FIT-CHEK362017-11-02
M769FITCHEK331FIT-CHEK332019-06-22
M769FITCHEK341FIT-CHEK342018-06-26
M769MAUTEST371URINE COLLECTION KIT372020-09-18
M769MAUTEST391URINE COLLECTION KIT392020-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M769HIVSTANDARD211HIV-1 Standard Test SystemHome Access Health CorporationMVZ2015-09-03
00608337000108OraSure HIV-1 Oral Specimen Collection DeviceOrasure Technologies, Inc.MVZ2014-09-05
20608337000102OraSure HIV-1 Oral Specimen Collection DeviceOrasure Technologies, Inc.MVZ2014-09-05
00608337000863OraSure HIV-1 Western Blot KitOrasure Technologies, Inc.MVZ2014-09-05