Zhejiang Quark Biotechnology Co., Ltd · 89-08 · CHINA
For Zhejiang Quark Biotechnology Co., Ltd, 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 C-19 Quik Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 03/11/2021; address is Zhejiang Xinchang High-Tech Ind. Park, Xinchang , 1 Jiang East Rd; Diankouzhen Zhuji , Shaoxing, Zhejiang CHINA, verified against its source on 2026-09-30.
- Firm
- Zhejiang Quark Biotechnology 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
- CHINA verified
- Address
- Zhejiang Xinchang High-Tech Ind. Park, Xinchang , 1 Jiang East Rd; Diankouzhen Zhuji , Shaoxing, Zhejiang CHINA verified
- Date published
- 03/11/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- C-19 Quik Test verified
What the source says
Zhejiang Quark Biotechnology Co., Ltd Date Published : 03/11/2021 Zhejiang Xinchang High-Tech Ind. Park, Xinchang , 1 Jiang East Rd; Diankouzhen Zhuji , Shaoxing, Zhejiang 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: 03/11/2021 Desc: C-19 Quik Test
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html