Healgen Scientific Covid-19 / Flu A&B Ag Combo Rapid Test Controls

Choose a Control Quantity Above
GCFC-PN2 : 1 Positive + 1 Negative Swab
GCFC-PN20 : 10 Positive + 10 Negative Swabs

For In Vitro Diagnostic Use
For Prescription Use Only
For Professional Use Only
For Emergency Use Authorization (EUA) Only

Intended Use

The External Controls - Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is a ready-to-use external control kit for use with the Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab). This kit is designed to verify proper test procedure and performance of the COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab).

Contents

• The positive control swabs are composed of a SARS-CoV-2 recombinant antigen, Influenza A recombinant antigen and Influenza B recombinant antigen extract dried onto a swab, with a red shaft, containing 0.05% Proclin 300 as a preservative.
• The negative control swabs are composed of negative control buffer dried onto a swab, with a blue shaft, containing 0.05% Proclin 300 as a preservative.
• External Controls Instructions for Use.

Control Kit Test Procedure

For the complete Test Procedure, refer to these sections in the Instructions For Use of the Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) kit.Healgen®COVID-19/Flu A&B Ag Combo Rapid Test.

• Follow Good Laboratory Practices, wear protective clothing, use disposal gloves, do not eat, drink, or smoke in the area.
• All the specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
• The control swab and test device should be discarded in a proper biohazard container after testing.
• The swab must be used within 2 hours of opening the sealed pouch.

Product Resources

Healgen Covid-19 / Flu A&B Combo Control Kit Instructions For Use (IFU) EUA