Mei Ning Kang Cheng China Biotechnology R&D Center, Inc. · 89-08 · CHINA
For Mei Ning Kang Cheng China Biotechnology R&D Center, Inc., 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 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 2026-09-30.
- Firm
- Mei Ning Kang Cheng China Biotechnology R&D Center, Inc. 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
- Rencai Building D-201 , 10 Xinghuo Road; Gaoxin Jizhu Kaifaqu Pukou District , Nanjing, Jiangsu CHINA verified
- Date published
- 10/28/2020 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. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices each item verified
- 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 each item verified
- 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 each item verified
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
— 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, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html