Genereach Biotech Corp · 89-08 · TAIWAN
For Genereach Biotech Corp, 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 POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 01/21/2022; address is 19 Keyuan 2nd Rd. , Xitun Dist. , Taichung City, TAIWAN, verified against its source on 2026-09-30.
- Firm
- Genereach Biotech Corp 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
- 19 Keyuan 2nd Rd. , Xitun Dist. , Taichung City, TAIWAN verified
- Date published
- 01/21/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent verified
What the source says
Genereach Biotech Corp Date Published : 01/21/2022 19 Keyuan 2nd Rd. , Xitun Dist. , Taichung 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: 01/21/2022 Desc: POCKIT Central SARS-CoV-2 (orf 1ab) Premix Reagent
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html