Racer Technology Pte Ltd · 89-08 · SINGAPORE
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
- 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
- Address
- 28 Changi South Street 1 , Singapore, SINGAPORE verified
- Date published
- 05/14/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- SARS-CoV-2 IgM/IgG Testing Kit | SARS-CoV-2 IgM/IgG (GICA) Test | Genabio SARS-CoV-2 IgM/IgG Testing Kit each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.