Racer Technology Pte Ltd · 89-08 · SINGAPORE

For Racer Technology Pte Ltd, import alert is 89-08; country is SINGAPORE; 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 SARS-CoV-2 IgM/IgG (GICA) Test | SARS-CoV-2 IgM/IgG Testing Kit | Genabio SARS-CoV-2 IgM/IgG Testing Kit; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 05/14/2021; address is 28 Changi South Street 1 , Singapore, SINGAPORE, verified against its source on 2026-09-30.

What the source says

Racer Technology Pte Ltd Date Published : 05/14/2021 28 Changi South Street 1 , Singapore, SINGAPORE

— accessdata.fda.gov, retrieved 2026-09-22

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.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.