Quidel Sofia User Manual

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Labels and Symbols
Label
Description
Manufacturer
In vitro diagnostic medical device
Prescription use only
Consult instructions for use
Authorized representative in the European Community
Temperature limitation
Directive 2002/06/EC on waste electrical and electronic equipment (WEEE)
SD Card
Serial Number
Catalog Number
Symbol
Description
Warning!
Indicates a hazardous situation, which if not avoided, could result in injury to
the Operator or a bystander (e.g., electrical shock or UV exposure).
Potential Biohazard!
An agent of biological origin that has the capacity to produce deleterious
effects on humans, i.e. microorganisms, toxins, and allergens derived from
those organisms; and allergens and toxins derived from higher plants and
animals.

Quidel Sofia Specifications

General

Detection Method	Fluorescence
Result Time	15 minutes
Humidity	10-90% non-condensing
Assay Type	Immunoassay
Storage Temperature	2°C to 30°C
Product Type	Point-of-Care Diagnostic
Technology	Fluorescence Immunoassay
Connectivity	USB
Operating Temperature	15-30°C
Reportable Range	Qualitative (Positive/Negative)