SPRING HEALTHCARE SERVICES AG · 89-08 · SWITZERLAND
For SPRING HEALTHCARE SERVICES AG · 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 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | COVID-19 Rapid IgM/IgG Combined Antibody Assay | Spring COVID-19 IgM/IgG Rapid Test Cassette; 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 2026-09-16.
- 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) | COVID-19 Rapid IgM/IgG Combined Antibody Assay | Spring COVID-19 IgM/IgG Rapid Test Cassette each item verified
What the source says
SPRING HEALTHCARE SERVICES AG Date Published : 05/14/2021 Obstgartenstrasse 5 , Affoltern Am Albis, Zurich SWITZERLAND 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: COVID-19 Rapid IgM/IgG Combined Antibody Assay 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: Spring COVID-19 IgM/IgG Rapid Test Cassette
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html