ZENUM SARL · 89-08 · SWITZERLAND
For ZENUM SARL · 89-08 · SWITZERLAND, 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 SWITZERLAND; product is SARS-CoV-2 IgG/IgM Rapid Test | ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test | ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - LW COVID-19 test home collection kit devices; date published is 03/02/2021; address is Route De La Corniche 3 , Epalinges, Vaud SWITZERLAND, verified against its source on 2026-09-16.
- Firm
- ZENUM SARL 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
- SWITZERLAND verified
- Address
- Route De La Corniche 3 , Epalinges, Vaud SWITZERLAND verified
- Date published
- 03/02/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - LW COVID-19 test home collection kit devices each item verified
- Product
- SARS-CoV-2 IgG/IgM Rapid Test | ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test | ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test each item verified
What the source says
ZENUM SARL Date Published : 03/02/2021 Route De La Corniche 3 , Epalinges, Vaud SWITZERLAND 83 Q - - KO Reagent, coronavirus serological Date Published: 08/25/2021 Desc: SARS-CoV-2 IgG/IgM Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 03/02/2021 Desc: ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid Test 83 Q - - LW COVID-19 test home collection kit devices Date Published: 03/02/2021 Desc: ZEKCOV19 3 ZEKMED COVID19 IgG/IgM Rapid 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.