Vela Operations Singapore Pte Ltd · 89-08 · SINGAPORE

For Vela Operations Singapore 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 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 2026-09-30.

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

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

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 2026-09-15

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.