HANGZHOU ZHEDA DIXUN BIOLOGICAL · 89-08 · CHINA
For HANGZHOU ZHEDA DIXUN BIOLOGICAL, import alert is 89-08; country is CHINA; 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 QuickZen COVID-19 IgM / IgG | QuickZen COVID-19 IgM / IgG; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological; date published is 03/02/2021; address is 2 No 568 Binkang Rd Bi , Hangzhou, CHINA, verified against its source on 2026-09-30.
- Firm
- HANGZHOU ZHEDA DIXUN BIOLOGICAL 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
- CHINA verified
- Address
- 2 No 568 Binkang Rd Bi , Hangzhou, CHINA verified
- Date published
- 03/02/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- QuickZen COVID-19 IgM / IgG | QuickZen COVID-19 IgM / IgG each item verified
What the source says
HANGZHOU ZHEDA DIXUN BIOLOGICAL Date Published : 03/02/2021 2 No 568 Binkang Rd Bi , Hangzhou, CHINA
— 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: 03/02/2021 Desc: QuickZen COVID-19 IgM / IgG 83 Q - - KO Reagent, coronavirus serological Date Published: 03/02/2021 Desc: QuickZen COVID-19 IgM / IgG
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html