CARDIAI INC. · 89-08 · CANADA

For CARDIAI INC., import alert is 89-08; country is CANADA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is CoviLAMP Screening Kit for SARS-CoV-2 | CoviLamp Fluorometric Test Kit | CoviLamp High- throughput Fluorometric Test Kit | CoviLampTM SARS-CoV-2 High-throughput Fluorometric Test Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 09/30/2021; address is 201-3151 27 St Ne , Calgary, Alberta CANADA, verified against its source on 2026-09-30.

What the source says

CARDIAI INC. Date Published : 09/30/2021 201-3151 27 St Ne , Calgary, Alberta CANADA

— accessdata.fda.gov, retrieved 2026-09-22

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.