OSOM Flu SARS
OSOM Flu SARS-CoV-2 Combo Home - 1074
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.
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: QKP
Device Name: Coronavirus Antigen Detection Test System.
Device Class: N
Physical State: In vitro diagnostic device
Definition: The qualitative detection of coronavirus viral antigens directly from clinical specimens.
Submission Type ID: 8
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Antigen detection
Life Sustain Support Flag: N
Unclassified Reason: 11
Implant Flag: N
Target Area: Clinical specimens.
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 00742860000089
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
Device Id: 50742860100654
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00742860000089
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 10742860100656
Device Type: Unit of Use
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