Sofia 2 SARS Ag + FIA
Sofia 2 - 20405
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a fluorescent immunoassay method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: QVF
Device Name: Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Device Class: 2
Physical State: Simple qualitative in vitro diagnostic device
Definition: A simple point-of-care device to detect SARS-CoV-2 viral targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Detection of SARS-CoV-2 viral targets directly from human clinical specimens
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Direct human clinical specimens
Regulation Number: 866.3982
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 30014613339755
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