Universal Buffer

GUDID 00628451188094

Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4) is a single use, qualitatitve immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the 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 ID00628451188094
NIH Device Record Key91174673-86e8-4b5a-807d-b826476ced62
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Buffer
Version Model Number815311007606
Company DUNS243757049
Company NameMedMira Laboratories Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com
Phone902-450-1588
Emailjennifer.maclellan@medmira.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100628451188094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MZFTest, Hiv Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-01-19

Devices Manufactured by MedMira Laboratories Inc

00628451188278 - MedMira Rapid H. Pylori Antibody Test2024-07-17 The MedMira Rapid H. Pylori Antibody Test is a rapid flow through test developed and manufactured by MedMira Laboratories Inc.
00628451188186 - Reveal G4 Rapid HIV-1/2 Antibody Test2024-04-19 Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunod
00628451188193 - Reveal G4 Rapid HIV-1/2 Antibody Test2024-04-19 Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunod
00628451188209 - HIV-1/2 Antibody Test Controls2024-04-19 HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These T
10628451188213 - HIV-1/2 Antibody Test Controls2024-04-19 HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These T
10628451188220 - Reveal G4 Rapid HIV-1/2 Antibody Test2024-04-19 Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunod
10628451188237 - Reveal G4 Rapid HIV-1/2 Antibody Test2024-04-19 Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunod
10628451188244 - Reveal G4 Rapid HIV-1/2 Antibody Test2024-04-19 Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunod
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