STERIPACK MEDICAL POLAND SP. Z O. O. · 89-08 · POLAND
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
- 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
- Address
- Ul. Japonska 1 , Jelcz-Laskowice, Dolnoslaskie POLAND verified
- Date published
- 09/30/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- BiologyWorks k(now) COVID-19 Molecular Test verified
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
— 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.