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DPP Zika IgM System

Chembio Diagnostic Systems Inc. · Model 65-9560-0 · UDI-DI 00607158000106

510(k) clearances

Adverse events

Recalls

Facilities

Description

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-EDTA plasma, potassium EDTA venous whole blood, or fingerstick whole blood specimens, collected from individuals meeting the CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated).

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.