# STERIPACK MEDICAL POLAND SP. Z O. O. · 89-08 · POLAND — FDA import alert red lists: firms subject to detention without physical examination

For STERIPACK MEDICAL POLAND SP. Z O. O. · 89-08 · POLAND, 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 POLAND; product is BiologyWorks k(now) COVID-19 Molecular Test; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 09/30/2021; address is Ul. Japonska 1 , Jelcz-Laskowice, Dolnoslaskie POLAND, verified against its source on 2026-09-16.

- **Firm:** STERIPACK MEDICAL POLAND SP. Z O. O. _(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:** POLAND _(verified: appears in the quote below)_
- **Address:** Ul. Japonska 1 , Jelcz-Laskowice, Dolnoslaskie POLAND _(verified: appears in the quote below)_
- **Date published:** 09/30/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: appears in the quote below)_
- **Product:** BiologyWorks k(now) COVID-19 Molecular Test _(verified: appears in the quote below)_

## What the source says

> STERIPACK MEDICAL POLAND SP. Z O. O. Date Published : 09/30/2021 Ul. Japonska 1 , Jelcz-Laskowice, Dolnoslaskie POLAND 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: BiologyWorks k(now) COVID-19 Molecular Test

## 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/).