Chembio DPP™ Zika IgM Control Pack

Description

Includes

1 DPP Zika Reactive Control, 1 DPP Zika Nonreactive Control, 1 Product Insert

An external control kit for use with DPP™ Zika IgM Assay System

• Contains enough to perform 25 tests
• Includes 2 vials:  reactive control and nonreactive control
• Ready to use reagents
• Controls are not kit lot specific and  may be interchanged between different DPP™ Zika IgM Assay System Lots

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Specifications

• Content And Storage: -20°C
• Detectable Analytes: Antibodies
• Type: liquid
• Formulation: liquid
• For Use With (Application): DPP Zika IgM assay system
• Includes: 1 DPP Zika Reactive Control, 1 DPP Zika Nonreactive Control, 1 Product Insert
• Packaging Type: Box
• Quantity: 2 Vials
• Form: Liquid

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.