Genzyme Virotech Gmbh · 89-08 · GERMANY
For Genzyme Virotech Gmbh · 89-08 · GERMANY, 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 GERMANY; product is SARS-CoV-2 IgG ELISA Test Kit | Gold Standard Diagnostics SARS-CoV-2 IgA 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 2026-09-16.
- 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
- SARS-CoV-2 IgG ELISA Test Kit | Gold Standard Diagnostics SARS-CoV-2 IgA 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 83 Q - - KO Reagent, coronavirus serological Date Published: 04/19/2022 Desc: SARS-CoV-2 IgG ELISA Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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