FDA.reportPublic FDA data

DPP HIV-Syphilis

Primary DI
00607158000083
Brand
DPP HIV-Syphilis
Company
Chembio Diagnostic Systems Inc.
Model
65-9502-0
Device description
The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2), and/or Treponema pallidum bacteria (the causative agent of syphilis) in fingerstick whole blood, potassium-EDTA venous whole blood or potassium-EDTA plasma specimens. The test is intended to be used with the DPP Micro Reader. The test is intended for use by trained professionals in point of care and laboratory settings to aid in the diagnosis of HIV and syphilis infection.
Published
2020-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
MZFTest, Hiv Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIPEnzyme Linked Immunoabsorption Assay, Treponema PallidumMicrobiology2
MZFTest, Hiv DetectionMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BP1801910

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BP1801910

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607158000083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607158000083006071580000836071580000830607158000083

GMDN Terms#

Term, Definition table
TermDefinition
HIV1/HIV2/Treponema pallidum antibody IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) and Treponema pallidum, the bacteria associated with syphilis, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly 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
160348470
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08100322953854Procise IFX53852024-08-16
08100322954301Procise ADL54302024-08-16
08100322954295ProciseDx Calibration Cartridge54292024-08-06
08100322943909ProciseDx Analyzer43902024-08-05
00607158000113DPP Zika IgM Micro Reader70-1064-070-1064-02021-10-19
00607158000106DPP Zika IgM System65-9560-02020-08-06
00607158000007Chembio DPP HIV 1/2 Assay65-9500-02014-09-01
00607158000021Clearview Complete HIV 1/260-9523-02014-09-01
00607158000038Clearview HIV Reactive/Nonreactive Controls60-9546-02014-09-01
00607158000045Chembio DPP HIV 1/2 Rapid Test Control Pack60-9552-02014-09-01
00607158000052Chembio HIV 1/2 Stat-Pak Assay60-9505-12014-09-01
00607158000069Chembio SURE CHECK HIV 1/2 Assay60-9507-02016-06-01
00607158000076Chembio HIV Reactive/Nonreactive Controls60-9549-02014-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590763626Access Syphilis ReagentBeckman Coulter, Inc.LIP2025-05-07
00875197006384cobas® HIV-1/HIV-2 QualitativeRoche Molecular Systems, Inc.MZF2025-03-31
10758750035052VITROSORTHO CLINICAL DIAGNOSTICSLIP2024-09-18
20758750035059VITROSORTHO CLINICAL DIAGNOSTICSLIP2024-09-18
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
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
03610522183692BioPlexBIO-RAD LABORATORIES, INC.LIP2023-07-28
03610522207992BioPlexBIO-RAD LABORATORIES, INC.LIP2023-07-28
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
07613336171950Elecsys SyphilisRoche Diagnostics GmbHLIP2022-03-15
07613336171998Elecsys SyphilisRoche Diagnostics GmbHLIP2022-03-15
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