GENEONE DIAGNOSTIC CO LTD · 89-08 · TAIWAN
For GENEONE DIAGNOSTIC CO LTD, import alert is 89-08; country is TAIWAN; 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 GeneOne COVID-19 Nucleic Acid Diagnostic Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 06/08/2022; address is Xinyi Dist., Taipei City, 110 Taiwan (R.O.C.) , Rm. 2; 5f., No.51, Sec.2, Keelung Rd , Taipei City, TAIWAN, verified against its source on 2026-09-30.
- Firm
- GENEONE DIAGNOSTIC CO 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
- TAIWAN verified
- Address
- Xinyi Dist., Taipei City, 110 Taiwan (R.O.C.) , Rm. 2; 5f., No.51, Sec.2, Keelung Rd , Taipei City, TAIWAN verified
- Date published
- 06/08/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- GeneOne COVID-19 Nucleic Acid Diagnostic Kit verified
What the source says
GENEONE DIAGNOSTIC CO LTD Date Published : 06/08/2022 Xinyi Dist., Taipei City, 110 Taiwan (R.O.C.) , Rm. 2; 5f., No.51, Sec.2, Keelung Rd , Taipei City, TAIWAN
— 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: 06/08/2022 Desc: GeneOne COVID-19 Nucleic Acid Diagnostic Kit
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html