NOTICE

The DropTM COVID-19 antibody test performed by CoreMedica, established in 2020 in Lee’s Summit, Missouri, USA, specializes in minimally invasive testing. CoreMedica is a CLIA licensed and CAP Accredited Laboratory.

 

Laboratory Testing

CoreMedica’s SARS-CoV-2 virus IgG and IgM antibody test is under the regulatory jurisdiction of the U.S. Department of Health and Human Services who enforces the Clinical Laboratory Improvement Amendments (CLIA) program. Any organization must have a CLIA certificate in order to provide clinical laboratory services in the United States. The CLIA program is administrated by the Centers of Medicare and Medicaid (CMS), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). PEUA200459

The ELISA testing methodology used by CoreMedica for antibodies detection does not require Health Canada approval because the test is completed using a standardized laboratory technique in a licensed laboratory in the United States and ordered by a licensed Canadian physician.

 

Dry Blood Spot Collection Device

The HemaSpot-SE Blood Collection and Transport Device is listed with the FDA as a Class I device (general controls), Product Code: NNK, and under 21 CFR 864.3250. This device is exempt from the premarket notification and does not require FDA approval.

In Canada, CoreMedica has filed their HemaSpot-SE™ Collection Device with Health Canada and are awaiting approval that this device meets the health and safety standards of Health Canada to collect blood drops. Therefore, blood collection using the HemaSpot-SE™ Collection Device in Canada will be performed under physician supervision until this device is approved by Health Canada.

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