Reference Source

DNANUDGE · 89-08 · UNITED KINGDOM

For DNANUDGE, 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 DnaNudge CovidNudge COVID-19 | CovidNudge; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 09/30/2021; address is 84 Wood Lane , Translation & Innovation Hub , London, Hmf UNITED KINGDOM, verified against its source on 2026-09-30.

Firm
DNANUDGE 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
84 Wood Lane , Translation & Innovation Hub , London, Hmf UNITED KINGDOM verified
Date published
09/30/2021 verified
Product code
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid each item verified
Product
DnaNudge CovidNudge COVID-19 | CovidNudge each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

DNANUDGE Date Published : 09/30/2021 84 Wood Lane , Translation & Innovation Hub , London, Hmf UNITED KINGDOM

— accessdata.fda.gov, retrieved 2026-09-22

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: DnaNudge CovidNudge COVID-19 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: CovidNudge

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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