FDA.reportPublic FDA data

Reveal G4 Rapid HIV-1/2 Antibody Test

Primary DI
00628451188179
Brand
Reveal G4 Rapid HIV-1/2 Antibody Test
Company
MedMira Laboratories Inc
Model
815311007583
Device description
Reveal® G4 Rapid HIV-1/2 Antibody Test (Reveal® G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) 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 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapids tests are available, this test should be used in appropriate multi-test algorithms.
Published
2024-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MZFTest, Hiv Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZFTest, Hiv DetectionMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK2310150

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2310150

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628451188179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628451188179006284511881796284511881790628451188179

GMDN Terms#

Term, Definition table
TermDefinition
HIV1/HIV2 antibody IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
243757049
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10628451188213HIV-1/2 Antibody Test Controls8153110075452024-04-11
10628451188220Reveal G4 Rapid HIV-1/2 Antibody Test8153110075522024-04-11
10628451188237Reveal G4 Rapid HIV-1/2 Antibody Test8153110075692024-04-11
10628451188244Reveal G4 Rapid HIV-1/2 Antibody Test8153110075382024-04-11
10628451188251HIV-1/2 Antibody Test Controls8153110075212024-04-11
10628451188268HIV-1/2 Antibody Test Controls8153110075142024-04-11
10628451188169Reveal G4 Rapid HIV-1/2 Antibody Test8152110075072024-04-08
10628451188114Reveal G4 Rapid HIV-1 Antibody Test8153110075522016-01-19
00628451188278MedMira Rapid H. Pylori Antibody Test8153110038202024-07-09
00628451188186Reveal G4 Rapid HIV-1/2 Antibody Test8153110075762024-04-11
00628451188193Reveal G4 Rapid HIV-1/2 Antibody Test8153110005912024-04-11
00628451188209HIV-1/2 Antibody Test Controls8153110075902024-04-11
10628451188107HIV-1 Antibody Test Controls8153110075452016-01-19
10628451188121Reveal G4 Rapid HIV-1 Antibody Test8153110075692016-01-19
10628451188138Reveal G4 Rapid HIV-1 Antibody Test8153110075382016-01-19
10628451188145HIV-1 Antibody Test Controls8153110075212017-12-12
10628451188152HIV-1 Antibody Test Controls8153110075142018-02-12
00628451188049MedMira Universal Buffer1009785RDB-G31009785RDB-G32015-05-31
00628451188056Reveal G4 Rapid HIV-1 Antibody Test8153110075832016-04-30
00628451188063Reveal G4 Rapid HIV-1 Antibody Test8153110075762016-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00875197006384cobas® HIV-1/HIV-2 QualitativeRoche Molecular Systems, Inc.MZF2025-03-31
00608337001792OraQuick HIV Self-TestOrasure Technologies, Inc.MZF2024-09-05
00608337001808OraQuick HIV Self-TestOrasure Technologies, Inc.MZF2024-09-05
00628451188186Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
00628451188193Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
00628451188209HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
10628451188213HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
10628451188220Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
10628451188237Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
10628451188244Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-11
10628451188251HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
10628451188268HIV-1/2 Antibody Test ControlsMedMira Laboratories IncMZF2024-04-11
10628451188169Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-08
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00875197006476cobas® HBV/HCV/HIV-1 Control KitRoche Molecular Systems, Inc.MZF2021-12-10
07613336170182Elecsys HIV combi PTRoche Diagnostics GmbHMZF2021-09-16
07613336170212Elecsys HIV combi PTRoche Diagnostics GmbHMZF2021-09-16
00630414301280Atellica IM CHIVSiemens Healthcare Diagnostics Inc.MZF2021-01-15
00607158000083DPP HIV-SyphilisChembio Diagnostic Systems Inc.MZF2020-12-29
00686597010198INSTI HIV-1/HIV-2 Antibody TestBiolytical Laboratories IncMZF2020-09-30
00686597010303INSTI HIV-1 Control Test KitBiolytical Laboratories IncMZF2020-09-30
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