GENEONE DIAGNOSTIC CO LTD · 89-08 · TAIWAN
For GENEONE DIAGNOSTIC CO LTD · 89-08 · TAIWAN, 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 TAIWAN; 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 2026-09-16.
- 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 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/08/2022 Desc: GeneOne COVID-19 Nucleic Acid Diagnostic Kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.