AI DE Diagnostic Co., Ltd · 89-08 · CHINA (High-Tech Industrial Park , 141 Zhuzhou Road; Laoshan , Qingdao, Shandong CHINA)
For AI DE Diagnostic Co., Ltd (High-Tech Industrial Park , 141 Zhuzhou Road; Laoshan , Qingdao, Shandong CHINA), 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 SARS-CoV-2 IgG/IgM Antibody; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 04/20/2022; address is High-Tech Industrial Park , 141 Zhuzhou Road; Laoshan , Qingdao, Shandong CHINA, verified against its source on 2026-09-30.
- Firm
- AI DE 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
- CHINA verified
- Address
- High-Tech Industrial Park , 141 Zhuzhou Road; Laoshan , Qingdao, Shandong CHINA verified
- Date published
- 04/20/2022 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- SARS-CoV-2 IgG/IgM Antibody verified
What the source says
AI DE Diagnostic Co., Ltd Date Published : 04/20/2022 High-Tech Industrial Park , 141 Zhuzhou Road; Laoshan , Qingdao, Shandong 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: 04/20/2022 Desc: SARS-CoV-2 IgG/IgM Antibody
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html