ANYGO TECHNOLOGY · 89-08 · CHINA
For ANYGO TECHNOLOGY, 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 COVID-19 Capture ELISA Assay; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 05/14/2021; address is listed twice: D # 1117 , 89 Dayangfang Ro , Beijing, CHINA and 10b-Building A, Hang Bu , Futian Dist Shenzhen, CHINA, verified against its source on 2026-09-30.
- Firm
- ANYGO TECHNOLOGY 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
- D # 1117 , 89 Dayangfang Ro , Beijing, CHINA verified
- 10b-Building A, Hang Bu , Futian Dist Shenzhen, CHINA also listed
- Date published
- 05/14/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- COVID-19 Capture ELISA Assay verified
What the source says
ANYGO TECHNOLOGY Date Published : 05/14/2021 D # 1117 , 89 Dayangfang Ro , Beijing, 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 - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: COVID-19 Capture ELISA Assay
— all from accessdata.fda.gov, retrieved 2026-09-15
The same source also states
ANYGO TECHNOLOGY Date Published : 05/14/2021 10b-Building A, Hang Bu , Futian Dist Shenzhen, CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html