Artron Laboratories, Inc. · 89-08 · CANADA

For Artron Laboratories, 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 COVID-19 IgM/IgG Antibody Test | COVID-19 IgM/IgG Antibody Test | OTO-Artron COVID-19 IgM/IgG Antibody Rapid Detection | COVID-19 IgM/IgG Antibody Test | Artron COVID-19 Antigen 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 2026-09-30.

What the source says

Artron Laboratories, Inc. Date Published : 06/23/2020 3938 North Fraser Way , Burnaby, British Columbia 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.