# Mei Ning Kang Cheng China Biotechnology R&D Center, Inc. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Mei Ning Kang Cheng China Biotechnology R&D Center, Inc. · 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 IGM & IGG QUANTUM DOT IMMUNOASSAY | SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY | SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY | SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY; 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. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/28/2020; address is Rencai Building D-201 , 10 Xinghuo Road; Gaoxin Jizhu Kaifaqu Pukou District , Nanjing, Jiangsu CHINA, verified against its source on 2026-09-16.

- **Firm:** Mei Ning Kang Cheng China Biotechnology R&D Center, Inc. _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Rencai Building D-201 , 10 Xinghuo Road; Gaoxin Jizhu Kaifaqu Pukou District , Nanjing, Jiangsu CHINA _(verified: appears in the quote below)_
- **Date published:** 10/28/2020 _(verified: appears in the quote below)_
- **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. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices _(verified: each item appears in the quote below)_
- **Product:** SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY | SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY | SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY | SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY _(verified: each item appears in the quote below)_
- **FDA notes:** Class III device, requires 510(k), or de novo application | Class III device, requires 510(k), or de novo application | Class III device, requires 510(k), or de novo application | Class III device, requires 510(k), or de novo application _(verified: each item appears in the quote below)_

## What the source says

> Mei Ning Kang Cheng China Biotechnology R&D Center, Inc. Date Published : 10/28/2020 Rencai Building D-201 , 10 Xinghuo Road; Gaoxin Jizhu Kaifaqu Pukou District , Nanjing, Jiangsu CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/28/2020 Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY Notes: Class III device, requires 510(k), or de novo application 83 Q - - KO Reagent, coronavirus serological Date Published: 10/28/2020 Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY Notes: Class III device, requires 510(k), or de novo application 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/28/2020 Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY Notes: Class III device, requires 510(k), or de novo application 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/28/2020 Desc: SARS-COV-2 IGM & IGG QUANTUM DOT IMMUNOASSAY Notes: Class III device, requires 510(k), or de novo application

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).