CHRONOMICS LTD · 89-08 · UNITED KINGDOM
For CHRONOMICS LTD, import alert is 89-08; country is UNITED KINGDOM; 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 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 2026-09-30.
- Firm
- CHRONOMICS 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
- UNITED KINGDOM verified
- Address
- 1st James Court , Norwich, UNITED KINGDOM verified
- Date published
- 09/30/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - LW COVID-19 test home collection kit devices each item verified
- Product
- SaliVIR Rapid Multiplex COVID19 vRNA Test | SaliVIR OME Collection kit each item verified
What the source says
CHRONOMICS LTD Date Published : 09/30/2021 1st James Court , Norwich, UNITED KINGDOM
— 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.
Product code and Product
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html