Chembio DPP HIV 1/2 Assay

GUDID 00607158000007

The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of DPP HIV Running Buffer, 20 Sampletainer Bottles, 20 Oral Fluid Swabs, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.

Chembio Diagnostic Systems Inc.

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

• Primary Device ID: 00607158000007
• NIH Device Record Key: cab0775b-bf7a-4bec-a1e4-eec58eec5b02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chembio DPP HIV 1/2 Assay
• Version Model Number: 65-9500-0
• 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	00607158000007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP120032

FDA Product Code

• MZF: Test, Hiv Detection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-01

Devices Manufactured by Chembio Diagnostic Systems Inc.

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• 00607158000007 - Chembio DPP HIV 1/2 Assay: 2018-07-06The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of DPP HIV Running Buffer, 20 Sampletainer Bottles, 20 Oral Fluid Swabs, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.
• 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
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• 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