The DPP Zika IgM System is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human serum (plain or separation gel), potassium
DPP Zika IgM System - 65-9560-0
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Zika virus in a clinical specimen, using an enzyme immunoassay (EIA) method.
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Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Device Name: Zika Virus Serological Reagents
Device Class: 2
Physical State: In Vitro Diagnostic antigens and antisera; ELISA Kit including different components, i.e., ELISA plates coated with antibodies, other capture antibodies, positive and negative controls etc.
Definition: Zika virus serological reagents are devices that consist of antigens and antisera for the diagnosis of Zika virus infection in human clinical specimens from individuals that have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The device aids in the presumptive clinical diagnosis of Zika virus infection in conjunction with other clinical and laboratory findings.
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Immunological methods e.g., ELISA
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Human serum or plasma or whole blood or body fluid collected from patient; none of the body parts will utilize the device or are intended to be affected by the device.
Regulation Number: 866.3935
Third Party Flag: N
Medical Specialty: MIDevice Identifiers
Device Id: 00607158000106
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A