ICT INTERNATIONAL · 89-08 · SOUTH AFRICA
For ICT INTERNATIONAL, import alert is 89-08; country is SOUTH AFRICA; 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)"; product is 2019-nCoV IgG/IgM Rapid Test Cassette | 2019-nCoV IgG/IgM Rapid Test Cassette | 2019-nCoV IgG/IgM Rapid Test Cassette; 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 07/17/2020; address is 271 De Goerde , Cape Town, SOUTH AFRICA, verified against its source on 2026-09-30.
- Firm
- ICT INTERNATIONAL 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
- 271 De Goerde , Cape Town, SOUTH AFRICA verified
- Date published
- 07/17/2020 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
- 2019-nCoV IgG/IgM Rapid Test Cassette | 2019-nCoV IgG/IgM Rapid Test Cassette | 2019-nCoV IgG/IgM Rapid Test Cassette each item verified
What the source says
ICT INTERNATIONAL Date Published : 07/17/2020 271 De Goerde , Cape Town, SOUTH AFRICA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/17/2020 Desc: 2019-nCoV IgG/IgM Rapid Test Cassette 83 Q - - KO Reagent, coronavirus serological Date Published: 07/17/2020 Desc: 2019-nCoV IgG/IgM Rapid Test Cassette 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/17/2020 Desc: 2019-nCoV IgG/IgM Rapid Test Cassette
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html