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

For Vela Operations Singapore 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 ViroKey Flu A/B & RSV RT-PCR Extension Kit (For use with ViroKey SARS-CoV-2 RT-PCR Test v2;0) pin 301073; product code is 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 12/03/2021; address is 50 Science Park Road , #05-07 The Kendall , Singapore, Central Singapore SINGAPORE, verified against its source on 2026-09-16.

- **Firm:** Vela Operations Singapore 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:** 50 Science Park Road , #05-07 The Kendall , Singapore, Central Singapore SINGAPORE _(verified: appears in the quote below)_
- **Date published:** 12/03/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices _(verified: appears in the quote below)_
- **Product:** ViroKey Flu A/B & RSV RT-PCR Extension Kit (For use with ViroKey SARS-CoV-2 RT-PCR Test v2;0) pin 301073 _(verified: appears in the quote below)_

## What the source says

> Vela Operations Singapore Pte Ltd Date Published : 12/03/2021 50 Science Park Road , #05-07 The Kendall , Singapore, Central Singapore SINGAPORE 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 12/03/2021 Desc: ViroKey Flu A/B & RSV RT-PCR Extension Kit (For use with ViroKey SARS-CoV-2 RT-PCR Test v2;0) pin 301073

## 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/).