# CARDIAI INC. · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For CARDIAI INC. · 89-08 · CANADA, import alert is 89-08; 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)"; country is CANADA; product is CoviLampTM SARS-CoV-2 High-throughput Fluorometric Test Kit | CoviLamp High- throughput Fluorometric Test Kit | CoviLamp Fluorometric Test Kit | CoviLAMP Screening Kit for SARS-CoV-2; 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 2026-09-16.

- **Firm:** CARDIAI INC. _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CANADA _(verified: appears in the quote below)_
- **Address:** 201-3151 27 St Ne , Calgary, Alberta CANADA _(verified: appears in the quote below)_
- **Date published:** 09/30/2021 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** CoviLampTM SARS-CoV-2 High-throughput Fluorometric Test Kit | CoviLamp High- throughput Fluorometric Test Kit | CoviLamp Fluorometric Test Kit | CoviLAMP Screening Kit for SARS-CoV-2 _(verified: each item appears in the quote below)_

## What the source says

> CARDIAI INC. Date Published : 09/30/2021 201-3151 27 St Ne , Calgary, Alberta CANADA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: CoviLampTM SARS-CoV-2 High-throughput Fluorometric Test Kit 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: CoviLamp High- throughput Fluorometric Test Kit 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: CoviLamp Fluorometric Test Kit 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: CoviLAMP Screening Kit for SARS-CoV-2

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).