SHANGDONG THINKLAB BIOTECHNOLOGY · 89-08 · CHINA
For SHANGDONG THINKLAB BIOTECHNOLOGY, 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 2019-nCoV IgM/IgG antibody Test Kit (Colloidal-gold Assay); product code is 83 Q - - KO Reagent, coronavirus serological; date published is 05/14/2021; address is No 1 Workshop No 10 Ind , Jining, CHINA, verified against its source on 2026-09-30.
- Firm
- SHANGDONG THINKLAB BIOTECHNOLOGY 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
- No 1 Workshop No 10 Ind , Jining, CHINA verified
- Date published
- 05/14/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- 2019-nCoV IgM/IgG antibody Test Kit (Colloidal-gold Assay) verified
What the source says
SHANGDONG THINKLAB BIOTECHNOLOGY Date Published : 05/14/2021 No 1 Workshop No 10 Ind , Jining, 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: 2019-nCoV IgM/IgG antibody Test Kit (Colloidal-gold Assay)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html