Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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