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

For WALLAC OY · 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 GSP/DELFIA Anti-SARS-CoV-2 IgG Kit; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 03/11/2021; address is Mustionkatu 6 , Turku Varsinais-Suomi, Southwest Finland FINLAND, verified against its source on 2026-09-16.

- **Firm:** WALLAC OY _(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:** Mustionkatu 6 , Turku Varsinais-Suomi, Southwest Finland FINLAND _(verified: appears in the quote below)_
- **Date published:** 03/11/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological _(verified: appears in the quote below)_
- **Product:** GSP/DELFIA Anti-SARS-CoV-2 IgG Kit _(verified: appears in the quote below)_

## What the source says

> WALLAC OY Date Published : 03/11/2021 Mustionkatu 6 , Turku Varsinais-Suomi, Southwest Finland FINLAND 83 Q - - KO Reagent, coronavirus serological Date Published: 03/11/2021 Desc: GSP/DELFIA Anti-SARS-CoV-2 IgG Kit

## 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/).