SPRING HEALTHCARE SERVICES AG · 89-08 · SWITZERLAND
For SPRING HEALTHCARE SERVICES AG, import alert is 89-08; country is SWITZERLAND; 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 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Spring COVID-19 IgM/IgG Rapid Test Cassette | COVID-19 Rapid IgM/IgG Combined Antibody Assay; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 05/14/2021; address is Obstgartenstrasse 5 , Affoltern Am Albis, Zurich SWITZERLAND, verified against its source on 2026-09-30.
- Firm
- SPRING HEALTHCARE SERVICES AG 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
- Obstgartenstrasse 5 , Affoltern Am Albis, Zurich SWITZERLAND verified
- Date published
- 05/14/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Spring COVID-19 IgM/IgG Rapid Test Cassette | COVID-19 Rapid IgM/IgG Combined Antibody Assay each item verified
What the source says
SPRING HEALTHCARE SERVICES AG Date Published : 05/14/2021 Obstgartenstrasse 5 , Affoltern Am Albis, Zurich SWITZERLAND
— accessdata.fda.gov, retrieved 2026-09-22
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 - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: Spring COVID-19 IgM/IgG Rapid Test Cassette 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: COVID-19 Rapid IgM/IgG Combined Antibody Assay
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html