VITROS Immunodiagnostic Products Anti
VITROS - 6199923
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a chemiluminescent immunoassay method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.
- May be stored frozen, no more than 1 freeze-thaw cycle
No Data Available
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Device Name: Reagent, Coronavirus Serological
Device Class: N
Physical State: In vitro diagnostic device.
Definition: The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens.
Submission Type ID: 8
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Serological assay.
Life Sustain Support Flag: N
Unclassified Reason: 11
Implant Flag: N
Target Area: Detection and differentiation of IgM and/or IgG antibodies from human specimens.
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/ADevice Identifiers
Device Id: 10758750033393
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