Duns Number:243757049
Device Description: Reveal G3 Rapid HIV-1 Antibody Test is a single use, qualitative immunoassay to detect ant Reveal G3 Rapid HIV-1 Antibody Test is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human serum or plasma. The Reveal G3 Rapid HIV-1 Antibody Test is intended for use as a point-of-care test to aid in diagnosis of infection with HIV-1. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
Catalog Number
815311000591
Brand Name
Reveal G3 Rapid HIV-1 Antibody Test
Version/Model Number
815311000591
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2016
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BP000023
Product Code
MZF
Product Code Name
Test, Hiv Detection
Public Device Record Key
20c8fba8-d329-45dd-89eb-7a39ce616d35
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
October 17, 2014
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |