JIANGSU MACRO & MICRO- TEST MED-TECH CO LTD · 89-08 · CHINA
For JIANGSU MACRO & MICRO- TEST MED-TECH 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 SARS-CoV-2 IgG/IgM Rapid Assay Kit (Colloidal Gold); product code is 83 Q - - KO Reagent, coronavirus serological; date published is 01/06/2022; address is Life And Health , No. 888 Zhu Jiang Road; Juegangzhen Rudongxian , Nantong, Jiangsu CHINA, verified against its source on 2026-09-30.
- Firm
- JIANGSU MACRO & MICRO- TEST MED-TECH 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
- Life And Health , No. 888 Zhu Jiang Road; Juegangzhen Rudongxian , Nantong, Jiangsu CHINA verified
- Date published
- 01/06/2022 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- SARS-CoV-2 IgG/IgM Rapid Assay Kit (Colloidal Gold) verified
What the source says
JIANGSU MACRO & MICRO- TEST MED-TECH CO LTD Date Published : 01/06/2022 Life And Health , No. 888 Zhu Jiang Road; Juegangzhen Rudongxian , Nantong, Jiangsu 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: 01/06/2022 Desc: SARS-CoV-2 IgG/IgM Rapid Assay Kit (Colloidal Gold)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html