MEDSAN GMBH · 89-08 · GERMANY
For MEDSAN 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 MEDSAN COVID-19 IgM/IgG RAPID TEST | MEDSAN COVID-19 IgM/IgG RAPID TEST | MEDSAN COVID-19 IgM/IgG RAPID TEST; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 07/07/2020; address is Brandshofer Deich 10 , Hamburg, Hamburg GERMANY, verified against its source on 2026-09-16.
- Firm
- MEDSAN 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
- Brandshofer Deich 10 , Hamburg, Hamburg GERMANY verified
- Date published
- 07/07/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- MEDSAN COVID-19 IgM/IgG RAPID TEST | MEDSAN COVID-19 IgM/IgG RAPID TEST | MEDSAN COVID-19 IgM/IgG RAPID TEST each item verified
What the source says
MEDSAN GMBH Date Published : 07/07/2020 Brandshofer Deich 10 , Hamburg, Hamburg GERMANY 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/07/2020 Desc: MEDSAN COVID-19 IgM/IgG RAPID TEST 83 Q - - KO Reagent, coronavirus serological Date Published: 07/07/2020 Desc: MEDSAN COVID-19 IgM/IgG RAPID TEST 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/07/2020 Desc: MEDSAN COVID-19 IgM/IgG RAPID TEST
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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