FDA.reportPublic FDA data

HIV-1/2 Antibody Test Controls

Primary DI
00628451188209
Brand
HIV-1/2 Antibody Test Controls
Company
MedMira Laboratories Inc
Model
815311007590
Device description
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.
Published
2024-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
00628451188209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628451188209006284511882096284511882090628451188209

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

Contacts#

Phone, Email table
PhoneEmail
902-450-1588support@medmira.com

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
00628451188179Reveal G4 Rapid HIV-1/2 Antibody Test8153110075832024-04-10
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
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
00628451188179Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-10
10628451188169Reveal G4 Rapid HIV-1/2 Antibody TestMedMira Laboratories IncMZF2024-04-08
15099590745158ACCESS HIV Ag/Ab comboBeckman Coulter, Inc.MZF2024-03-15
00884999050853Alinity mABBOTT MOLECULAR INC.MZF2023-06-08
07613336215845Elecsys HIV DuoRoche Diagnostics GmbHMZF2022-09-22
00884999050402Alinity mABBOTT MOLECULAR INC.MZF2022-08-29
00875197006445cobas® NHP Negative Control KitRoche Molecular Systems, Inc.MZF2022-08-01
00811877011101Determine™ HIV–1/2 Ag/Ab Combo Alere Scarborough, Inc.MZF2022-01-13
00811877011125Determine™ HIV–1/2 Ag/Ab Combo Controls Alere Scarborough, Inc.MZF2022-01-13
00875197006483cobas HIV-1/HIV-2 Qualitative Control KitRoche Molecular Systems, Inc.MZF2021-12-14
00875197006407cobas® HIV-1Roche Molecular Systems, Inc.MZF2021-12-10
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
00686597010310INSTI HIV-1/HIV-2 Control Test KitBiolytical Laboratories IncMZF2020-09-30