PHARMACT GMBH · 89-08 · GERMANY
For PHARMACT 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 BelTEST It SARS CoV-2 IgM/IgG Rapid Test | BelTEST It SARS CoV-2 IgM/IgG Rapid Test | BelTEST It SARS CoV-2 IgM/IgG Rapid Test | BelTEST It SARS CoV-2 IgM/IgG Rapid Test; product code is 75 J - - KD Radioimmunoassay, C-Peptides Of Proinsulin | 83 O - - TG Non-sars coronavirus multiplex nucleic acid assay | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological; date published is 04/15/2021; address is Universitatsmedizin Haus 41 , Theodor-Kutzer-Ufer 1-3 , Mannheim, Baden-Wurttemberg GERMANY, verified against its source on 2026-09-16.
- Firm
- PHARMACT 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
- Universitatsmedizin Haus 41 , Theodor-Kutzer-Ufer 1-3 , Mannheim, Baden-Wurttemberg GERMANY verified
- Date published
- 04/15/2021 verified
- Product code
- 75 J - - KD Radioimmunoassay, C-Peptides Of Proinsulin | 83 O - - TG Non-sars coronavirus multiplex nucleic acid assay | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- BelTEST It SARS CoV-2 IgM/IgG Rapid Test | BelTEST It SARS CoV-2 IgM/IgG Rapid Test | BelTEST It SARS CoV-2 IgM/IgG Rapid Test | BelTEST It SARS CoV-2 IgM/IgG Rapid Test each item verified
What the source says
PHARMACT GMBH Date Published : 04/15/2021 Universitatsmedizin Haus 41 , Theodor-Kutzer-Ufer 1-3 , Mannheim, Baden-Wurttemberg GERMANY 75 J - - KD Radioimmunoassay, C-Peptides Of Proinsulin Date Published: 04/15/2021 Desc: BelTEST It SARS CoV-2 IgM/IgG Rapid Test 83 O - - TG Non-sars coronavirus multiplex nucleic acid assay Date Published: 04/15/2021 Desc: BelTEST It SARS CoV-2 IgM/IgG Rapid Test 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 04/15/2021 Desc: BelTEST It SARS CoV-2 IgM/IgG Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 04/15/2021 Desc: BelTEST It SARS CoV-2 IgM/IgG Rapid Test
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html