ARCDIA INTERNATIONAL OY LTD · 89-08 · FINLAND
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
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.