Duns Number:848511283
Device Description: The Home Access Health Corporation HIV-1 Standard Test System is intended for use by perso 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.
Catalog Number
-
Brand Name
HIV-1 Standard Test System
Version/Model Number
21
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BP950002
Product Code
MVZ
Product Code Name
System,Test,Home,Hiv-1
Public Device Record Key
ae91c3c1-8168-454d-a853-a9def772088d
Public Version Date
November 23, 2021
Public Version Number
5
DI Record Publish Date
September 03, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 2 |