SHENZHEN LANDWIND HEALTH SCIENCE& TECHNOLOGY CO. · 89-08 · CHINA
For SHENZHEN LANDWIND HEALTH SCIENCE& TECHNOLOGY CO. · 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 COVID-19 IgG/IgM RAPID TEST | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing) | COVID-19 IgG/IgM RAPID TEST | COVID-19 IgG/IgM RAPID TEST; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 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 Block A4 Floor 8 , No. 1001 Xueyuan; Nanshan District , Shenzhen, CHINA, verified against its source on 2026-09-16.
- Firm
- SHENZHEN LANDWIND HEALTH SCIENCE& TECHNOLOGY CO. 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
- Block A4 Floor 8 , No. 1001 Xueyuan; Nanshan District , Shenzhen, CHINA verified
- Date published
- 06/22/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 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
- COVID-19 IgG/IgM RAPID TEST | Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing) | COVID-19 IgG/IgM RAPID TEST | COVID-19 IgG/IgM RAPID TEST each item verified
What the source says
SHENZHEN LANDWIND HEALTH SCIENCE& TECHNOLOGY CO. Date Published : 06/22/2020 Block A4 Floor 8 , No. 1001 Xueyuan; Nanshan District , Shenzhen, CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/22/2020 Desc: COVID-19 IgG/IgM RAPID TEST 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/06/2021 Desc: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing) 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2020 Desc: COVID-19 IgG/IgM RAPID TEST 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2020 Desc: COVID-19 IgG/IgM RAPID TEST
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html