*For Professional Use Only*
|Date EUA Issued||Manufacturer||Diagnostic (Letter of Authorization)||Technology||Authorized Setting(s)1||Authorization Documents2||Other Documents/|
|05/29/2020||Healgen Scientific LLC||COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)||Serology IgM and IgG||H, M||HCP, Recipients, IFU||None|
FDA EUA AUTHORIZED
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COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.
The test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
All clinical study reports and data have been completed and are pending FDA Approval.
If you develop emergency warning signs for COVID-19 get medical attention immediately. Emergency warning signs include*:
- Difficulty breathing or shortness of breath
- Persistent pain or pressure in the chest
- New confusion or inability to arouse
- Bluish lips or face
*This list is not all inclusive. Please consult your medical provider for any other symptoms that are severe or concerning.
Case of 500 Includes - 500 Test Cassettes, 500 Droppers, 20 Bottles of Buffer, 20 Product Inserts
*One bottle of buffer per box of 25. (Each test requires 2 drops of buffer. A bottle of buffer contains 50 drops.)
*Lancets and Alcohol Prep Pads are not included
The virus is thought to spread mainly from person-to-person.
- Between people who are in close contact with one another (within about 6 feet).
- Via respiratory droplets produced when an infected person coughs or sneezes.
- These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.