Reference Source

JIANGSU MACRO & MICRO- TEST MED-TECH CO LTD · 89-08 · CHINA

For JIANGSU MACRO & MICRO- TEST MED-TECH CO LTD · 89-08 · CHINA, import alert is 89-08; 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)"; country is CHINA; 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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 83 Q - - KO Reagent, coronavirus serological Date Published: 01/06/2022 Desc: SARS-CoV-2 IgG/IgM Rapid Assay Kit (Colloidal Gold)

accessdata.fda.gov, retrieved 2026-09-15

Source

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