Reveal G3 Rapid HIV-1 Antibody Test

Basic Information

• Brand Name: Reveal G3 Rapid HIV-1 Antibody Test
• Primary DI: 00628451188018
• Version / Model: 815311000591
• Catalog Number: 815311000591
• Company Name: MedMira Laboratories Inc
• Labeler DUNS: 243757049
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-10-17
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 20c8fba8-d329-45dd-89eb-7a39ce616d35
• Distribution End Date: 2016-10-31

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MZF	Test, Hiv Detection	Microbiology	866.3956	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48483	HIV1 antibody IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antibodies to the human immunodeficiency virus 1 (HIV1) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628451188018	GS1

Premarket Submissions

Submission Number	Supplement Number
BP000023	26

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius