SUZHOU KANGHESHUN MEDICAL TECHNOLOGY CO., LTD · 89-08 · CHINA
For SUZHOU KANGHESHUN MEDICAL TECHNOLOGY 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 Test Cassette | SARS-CoV-2 IgG/IgM Rapid Test Cassette | SARS-CoV-2 IgG/IgM Rapid Test Cassette; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2020; address is Building 29 Room 403 3 , Suzhou, Jiangsu CHINA, verified against its source on 2026-09-16.
- Firm
- SUZHOU KANGHESHUN MEDICAL TECHNOLOGY 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
- Building 29 Room 403 3 , Suzhou, Jiangsu CHINA verified
- Date published
- 06/22/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- SARS-CoV-2 IgG/IgM Rapid Test Cassette | SARS-CoV-2 IgG/IgM Rapid Test Cassette | SARS-CoV-2 IgG/IgM Rapid Test Cassette each item verified
What the source says
SUZHOU KANGHESHUN MEDICAL TECHNOLOGY CO., LTD Date Published : 06/22/2020 Building 29 Room 403 3 , Suzhou, Jiangsu CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/22/2020 Desc: SARS-CoV-2 IgG/IgM Rapid Test Cassette 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2020 Desc: SARS-CoV-2 IgG/IgM Rapid Test Cassette 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2020 Desc: SARS-CoV-2 IgG/IgM Rapid Test Cassette
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html