Reveal G3 Rapid HIV-1 Antibody Test 815311000591

GUDID 00628451188018

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.

MedMira Laboratories Inc

HIV1 antibody IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00628451188018
• NIH Device Record Key: 20c8fba8-d329-45dd-89eb-7a39ce616d35
• Commercial Distribution Discontinuation: 2016-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Reveal G3 Rapid HIV-1 Antibody Test
• Version Model Number: 815311000591
• Catalog Number: 815311000591
• Company DUNS: 243757049
• Company Name: MedMira Laboratories Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628451188018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP000023

FDA Product Code

• MZF: Test, Hiv Detection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-10-17

On-Brand Devices [Reveal G3 Rapid HIV-1 Antibody Test]

• 00628451188018: Reveal G3 Rapid HIV-1 Antibody Test is a single use, qualitative immunoassay to detect antibodie
• 10628451188022: Reveal G3 Rapid HIV-1 Antibody Test is a single use, qualitative immunoassay to detect antibodie