The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA, and citrate) by fluorescence immunoassay (FIA) using the FREND™ System.

The COVID
FREND COVID-19 total Ab - FREND COVID-19 total Ab

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to 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.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QKO

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/A

Device Id: 08809317540924

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