Mokobio Life Science Corporation · 89-08 · CHINA
For Mokobio Life Science Corporation · 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 Building 5 Floor 7-9 , 15 Abp; Area Fengtai District , Beijing, Beijing CHINA, verified against its source on 2026-09-16.
- Firm
- Mokobio Life Science Corporation 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 5 Floor 7-9 , 15 Abp; Area Fengtai District , Beijing, Beijing 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
Mokobio Life Science Corporation Date Published : 10/28/2020 Building 5 Floor 7-9 , 15 Abp; Area Fengtai District , Beijing, Beijing 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html