Chembio DPP™ Zika IgM Assay System

Description

Includes

20 Individually Pouched DPP™ Zika IgM Test Devices, 20 Disposable 10μL Microsafe™ Tubes, 20 Sample Vials, 20 Transfer Pipets (100μL), 1 DPP IgM Sample Buffer, Blue Cap, 1 DPP IgM Running Buffer, Yellow Cap, 1 Product Insert, 1 Quick Reference Guide, Fact sheet for patients, Fact sheet for Health care workers

The 15-minute rapid test for detecting Zika virus infection

For the detection of Zika virus IgM antibodies in fingerstick whole blood, EDTA venous whole blood, EDTA plasma and serum.

• Fast: Provides results in as little as 15 minutes
• Flexible: Detects Zika virus IgM antibodies from 8 days up to 12 weeks
• Easy to Use: Provides objective results using simple, handheld digital reader (DPP™ Micro Reader)
• Received FDA Emergency Use Authorization (EUA)

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Specifications

• Content And Storage: 2°C to 8°C
• Detectable Analytes: Zika Virus IgM
• Type: Rapid Test
• For Use With (Application): Detection of Zika virus infection in Fingerstick Whole Blood, Venous Whole blood, Serum, Plasma
• Includes: 20 Individually Pouched DPP™ Zika IgM Test Devices, 20 Disposable 10μL Microsafe™ Tubes, 20 Sample Vials, 20 Transfer Pipets (100μL), 1 DPP IgM Sample Buffer, Blue Cap, 1 DPP IgM Running Buffer, Yellow Cap, 1 Product Insert, 1 Quick Reference Guide, Fact sheet for patients, Fact sheet for Health care workers
• Quantity: 20
• Test Time: 15 min.

1. The test has not been FDA cleared or approved
2. The test has been authorized by FDA under an EUA for use by authorized laboratories
3. The text has been authorized only for the diagnosis of Zika virus infection and not for any other viruses or pathogens
4. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of the Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.