Reference Source

ICT INTERNATIONAL · 89-08 · SOUTH AFRICA

For ICT INTERNATIONAL · 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 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 2026-09-16.

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 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

accessdata.fda.gov, retrieved 2026-09-15

Source

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