Chembio SURE CHECK HIV 1/2 Assay

GUDID 00607158000069

The Chembio SURE CHECK® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Chembio SURE CHECK® 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 25 individually pouched tests each containing 1 Sampler with a Test Strip inside, 1 Buffer Vial attached to the Sampler (~350μL), 1 Sterile Safety Lancet, 1 Bandage, 1 Desiccant Packet; 25 Disposable Test Stands; 1 Product Insert; 25 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: 00607158000069
• NIH Device Record Key: 607a3ed4-8208-48a5-bd87-7ea8581a7467
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chembio SURE CHECK HIV 1/2 Assay
• Version Model Number: 60-9507-0
• 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: false
• 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	00607158000069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP050009

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: 2016-06-01

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