# ARCDIA INTERNATIONAL OY LTD · 89-08 · FINLAND — FDA import alert red lists: firms subject to detention without physical examination

For ARCDIA INTERNATIONAL OY LTD · 89-08 · FINLAND, 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 FINLAND; product is ArcDia mariPOC SARS CoV2 | mariPOC SARS-CoV-2 by ArcDia international Oy Ltd; product code is 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2021; address is Lemminkaisenkatu 32 Pl , Turku, FINLAND, verified against its source on 2026-09-16.

- **Firm:** ARCDIA INTERNATIONAL OY LTD _(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:** FINLAND _(verified: appears in the quote below)_
- **Address:** Lemminkaisenkatu 32 Pl , Turku, FINLAND _(verified: appears in the quote below)_
- **Date published:** 06/22/2021 _(verified: appears in the quote below)_
- **Product code:** 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:** ArcDia mariPOC SARS CoV2 | mariPOC SARS-CoV-2 by ArcDia international Oy Ltd _(verified: each item appears in the quote below)_

## What the source says

> ARCDIA INTERNATIONAL OY LTD Date Published : 06/22/2021 Lemminkaisenkatu 32 Pl , Turku, FINLAND 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: ArcDia mariPOC SARS CoV2 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: mariPOC SARS-CoV-2 by ArcDia international Oy Ltd

## 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/).