Vela Operations Singapore Pte Ltd · 89-08 · SINGAPORE
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
- 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
- 50 Science Park Road , #05-07 The Kendall , Singapore, Central Singapore SINGAPORE verified
- Date published
- 12/03/2021 verified
- Product code
- 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices verified
- 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
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
— 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.