# LIFEASSAY DIAGNOSTICS PTY LTD · 89-08 · SOUTH AFRICA — FDA import alert red lists: firms subject to detention without physical examination

For LIFEASSAY DIAGNOSTICS PTY LTD · 89-08 · SOUTH AFRICA, 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 SOUTH AFRICA; product is COVID-19 IgM/IgG Lateral Flow Assay | COVID-19 IgM/IgG Lateral Flow Assay | COVID-19 IgM/IgG Lateral Flow Assay; 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 06/22/2020; address is Capricorn Business Technology Pa , Trojan House Gateway CL , Cape Town, SOUTH AFRICA, verified against its source on 2026-09-16.

- **Firm:** LIFEASSAY DIAGNOSTICS PTY LTD _(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:** SOUTH AFRICA _(verified: appears in the quote below)_
- **Address:** Capricorn Business Technology Pa , Trojan House Gateway CL , Cape Town, SOUTH AFRICA _(verified: appears in the quote below)_
- **Date published:** 06/22/2020 _(verified: appears in the quote below)_
- **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. _(verified: each item appears in the quote below)_
- **Product:** COVID-19 IgM/IgG Lateral Flow Assay | COVID-19 IgM/IgG Lateral Flow Assay | COVID-19 IgM/IgG Lateral Flow Assay _(verified: each item appears in the quote below)_

## What the source says

> LIFEASSAY DIAGNOSTICS PTY LTD Date Published : 06/22/2020 Capricorn Business Technology Pa , Trojan House Gateway CL , Cape Town, SOUTH AFRICA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/22/2020 Desc: COVID-19 IgM/IgG Lateral Flow Assay 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2020 Desc: COVID-19 IgM/IgG Lateral Flow Assay 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2020 Desc: COVID-19 IgM/IgG Lateral Flow Assay

## 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/).