STERIPACK MEDICAL POLAND SP. Z O. O. · 89-08 · POLAND
For STERIPACK MEDICAL POLAND SP. Z O. O., import alert is 89-08; country is POLAND; 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 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 2026-09-30.
- 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
— 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 - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: BiologyWorks k(now) COVID-19 Molecular Test
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html