Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

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