# CHRONOMICS LTD · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For CHRONOMICS LTD · 89-08 · UNITED KINGDOM, 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 UNITED KINGDOM; product is SaliVIR Rapid Multiplex COVID19 vRNA Test | SaliVIR OME Collection kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - LW COVID-19 test home collection kit devices; date published is 09/30/2021; address is 1st James Court , Norwich, UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** CHRONOMICS 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:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** 1st James Court , Norwich, UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 09/30/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - LW COVID-19 test home collection kit devices _(verified: each item appears in the quote below)_
- **Product:** SaliVIR Rapid Multiplex COVID19 vRNA Test | SaliVIR OME Collection kit _(verified: each item appears in the quote below)_

## What the source says

> CHRONOMICS LTD Date Published : 09/30/2021 1st James Court , Norwich, UNITED KINGDOM 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: SaliVIR Rapid Multiplex COVID19 vRNA Test 83 Q - - LW COVID-19 test home collection kit devices Date Published: 09/30/2021 Desc: SaliVIR OME Collection 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/).