# Racer Technology Pte Ltd · 89-08 · SINGAPORE — FDA import alert red lists: firms subject to detention without physical examination

For Racer Technology Pte Ltd · 89-08 · SINGAPORE, 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 SINGAPORE; product is SARS-CoV-2 IgM/IgG Testing Kit | SARS-CoV-2 IgM/IgG (GICA) Test | 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 2026-09-16.

- **Firm:** Racer Technology Pte Ltd _(verified: appears in the quote below)_
- **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:** SINGAPORE _(verified: appears in the quote below)_
- **Address:** 28 Changi South Street 1 , Singapore, SINGAPORE _(verified: appears in the quote below)_
- **Date published:** 05/14/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological _(verified: each item appears in the quote below)_
- **Product:** SARS-CoV-2 IgM/IgG Testing Kit | SARS-CoV-2 IgM/IgG (GICA) Test | Genabio SARS-CoV-2 IgM/IgG Testing Kit _(verified: each item appears in the quote below)_

## What the source says

> Racer Technology Pte Ltd Date Published : 05/14/2021 28 Changi South Street 1 , Singapore, SINGAPORE 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: SARS-CoV-2 IgM/IgG Testing Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: SARS-CoV-2 IgM/IgG (GICA) Test 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: Genabio SARS-CoV-2 IgM/IgG Testing Kit

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).