Lifeassay Diagnostics (Pty) Ltd · 89-08 · SOUTH AFRICA
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 Lifeassay House , 7 Bell Crescent , Cape Town, Western Cape SOUTH AFRICA, verified against its source on 2026-09-16.
- Firm
- Lifeassay Diagnostics (Pty) Ltd 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
- SOUTH AFRICA verified
- Address
- Lifeassay House , 7 Bell Crescent , Cape Town, Western Cape SOUTH AFRICA verified
- Date published
- 06/22/2020 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
- COVID-19 IgM/IgG Lateral Flow Assay | COVID-19 IgM/IgG Lateral Flow Assay | COVID-19 IgM/IgG Lateral Flow Assay each item verified
What the source says
Lifeassay Diagnostics (Pty) Ltd Date Published : 06/22/2020 Lifeassay House , 7 Bell Crescent , Cape Town, Western Cape 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html