# PHARMACT GMBH · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Universitatsmedizin Haus 41 , Theodor-Kutzer-Ufer 1-3 , Mannheim, Baden-Wurttemberg GERMANY _(verified: appears in the quote below)_
- **Date published:** 04/15/2021 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).