DPP HIV-Syphilis

GUDID 00607158000083

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.

Chembio Diagnostic Systems Inc.

HIV1/HIV2/Treponema pallidum antibody IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00607158000083
• NIH Device Record Key: 3ff8d739-3adf-4deb-aab0-b6098755230f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DPP HIV-Syphilis
• Version Model Number: 65-9502-0
• Company DUNS: 160348470
• Company Name: Chembio Diagnostic Systems 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607158000083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP180191

FDA Product Code

• MZF: Test, Hiv Detection

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-06
• Device Publish Date: 2020-12-29

Devices Manufactured by Chembio Diagnostic Systems Inc.

• 00607158000113 - DPP Zika IgM Micro Reader: 2021-10-27 The DPP® Micro Reader for use with the DPP Zika IgM Assay System is a reflectance reader configured to read exclusive results o
• 00607158000083 - DPP HIV-Syphilis: 2021-01-06The 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.
• 00607158000083 - DPP HIV-Syphilis: 2021-01-06 The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immun
• 00607158000106 - DPP Zika IgM System: 2020-08-14 The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain
• 00607158000007 - Chembio DPP HIV 1/2 Assay: 2018-07-06 The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodefici
• 00607158000021 - Clearview Complete HIV 1/2: 2018-07-06 The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immun
• 00607158000038 - Clearview HIV Reactive/Nonreactive Controls: 2018-07-06 The Clearview® HIV Reactive/Nonreactive Controls are quality control reagents for use with the Clearview® COMPLETE HIV 1/2 Ass
• 00607158000045 - Chembio DPP HIV 1/2 Rapid Test Control Pack: 2018-07-06 The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio DPP HIV 1/2 Assay only. Chem
• 00607158000052 - Chembio HIV 1/2 Stat-Pak Assay: 2018-07-06 The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunod