ABLD · 89-08 · FRANCE
For ABLD, import alert is 89-08; country is FRANCE; 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 UltraGene Combo2Screen SARS-CoV-2 assay; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 11/24/2021; address is 33 Chemin Vicinal De L'Argile , Marseille 10e Arrondissement, Bouches-du-Rhone FRANCE, verified against its source on 2026-09-30.
- Firm
- ABLD 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
- FRANCE verified
- Address
- 33 Chemin Vicinal De L'Argile , Marseille 10e Arrondissement, Bouches-du-Rhone FRANCE verified
- Date published
- 11/24/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- UltraGene Combo2Screen SARS-CoV-2 assay verified
What the source says
ABLD Date Published : 11/24/2021 33 Chemin Vicinal De L'Argile , Marseille 10e Arrondissement, Bouches-du-Rhone FRANCE
— 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: 11/24/2021 Desc: UltraGene Combo2Screen SARS-CoV-2 assay
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html