CARDIAI INC. · 89-08 · CANADA

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
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
Address: 201-3151 27 St Ne , Calgary, Alberta CANADA verified
Date published: 09/30/2021 verified
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 each item verified
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 each item verified

Sourceaccessdata.fda.gov

Verified2026-09-16

Review by2026-11-15

DatasetFDA import alert red lists: firms subject to detention without physical examination

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

— accessdata.fda.gov, retrieved 2026-09-15

Source

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

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.

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CARDIAI INC. · 89-08 · CANADA

What the source says

Source

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