# Artron Laboratories, Inc. · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For Artron Laboratories, 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 COVID-19 IgM/IgG Antibody Test | COVID-19 IgM/IgG Antibody Test | OTO-Artron COVID-19 IgM/IgG Antibody Rapid Detection | Artron COVID-19 Antigen Test | COVID-19 IgM/IgG Antibody Test; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/23/2020; address is 3938 North Fraser Way , Burnaby, British Columbia CANADA, verified against its source on 2026-09-16.

- **Firm:** Artron Laboratories, 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:** 3938 North Fraser Way , Burnaby, British Columbia CANADA _(verified: appears in the quote below)_
- **Date published:** 06/23/2020 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** COVID-19 IgM/IgG Antibody Test | COVID-19 IgM/IgG Antibody Test | OTO-Artron COVID-19 IgM/IgG Antibody Rapid Detection | Artron COVID-19 Antigen Test | COVID-19 IgM/IgG Antibody Test _(verified: each item appears in the quote below)_

## What the source says

> Artron Laboratories, Inc. Date Published : 06/23/2020 3938 North Fraser Way , Burnaby, British Columbia CANADA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/23/2020 Desc: COVID-19 IgM/IgG Antibody Test 83 Q - - KO Reagent, coronavirus serological Date Published: 06/23/2020 Desc: COVID-19 IgM/IgG Antibody Test 83 Q - - KO Reagent, coronavirus serological Date Published: 12/23/2020 Desc: OTO-Artron COVID-19 IgM/IgG Antibody Rapid Detection 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/07/2021 Desc: Artron COVID-19 Antigen Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/23/2020 Desc: COVID-19 IgM/IgG Antibody Test

## 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/).