ARCDIA INTERNATIONAL OY LTD · 89-08 · FINLAND
For ARCDIA INTERNATIONAL OY LTD, import alert is 89-08; country is FINLAND; 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 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 2026-09-30.
- Firm
- ARCDIA INTERNATIONAL OY LTD 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
- FINLAND verified
- Address
- Lemminkaisenkatu 32 Pl , Turku, FINLAND verified
- Date published
- 06/22/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- ArcDia mariPOC SARS CoV2 | mariPOC SARS-CoV-2 by ArcDia international Oy Ltd each item verified
What the source says
ARCDIA INTERNATIONAL OY LTD Date Published : 06/22/2021 Lemminkaisenkatu 32 Pl , Turku, FINLAND
— accessdata.fda.gov, retrieved 2026-09-15
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.
Product code and Product
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html