Genzyme Virotech Gmbh · 89-08 · GERMANY
For Genzyme Virotech Gmbh, import alert is 89-08; country is GERMANY; 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 Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit | SARS-CoV-2 IgG ELISA Test Kit; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 01/26/2021; address is Lowenplatz 5 , Russelsheim Am Main, Hassia GERMANY, verified against its source on 2026-09-30.
- Firm
- Genzyme Virotech Gmbh 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
- GERMANY verified
- Address
- Lowenplatz 5 , Russelsheim Am Main, Hassia GERMANY verified
- Date published
- 01/26/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit | SARS-CoV-2 IgG ELISA Test Kit each item verified
What the source says
Genzyme Virotech Gmbh Date Published : 01/26/2021 Lowenplatz 5 , Russelsheim Am Main, Hassia GERMANY
— 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: 01/26/2021 Desc: Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 04/19/2022 Desc: SARS-CoV-2 IgG ELISA Test Kit
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html