# Da An Gene Co., Ltd. Of Sun Yat-Sen University · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Da An Gene Co., Ltd. Of Sun Yat-Sen University · 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 Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) | Assurance AB COVID-19 IgM/IgG Rapid Antibody Test; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological; date published is 01/26/2021; address is Science Park , No. 19 Xiangshan Road; High & New Technology , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Da An Gene Co., Ltd. Of Sun Yat-Sen University _(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:** Science Park , No. 19 Xiangshan Road; High & New Technology , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 01/26/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological _(verified: each item appears in the quote below)_
- **Product:** Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) | Assurance AB COVID-19 IgM/IgG Rapid Antibody Test _(verified: each item appears in the quote below)_

## What the source says

> Da An Gene Co., Ltd. Of Sun Yat-Sen University Date Published : 01/26/2021 Science Park , No. 19 Xiangshan Road; High & New Technology , Guangzhou, Guangdong CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: Assurance AB COVID-19 IgM/IgG Rapid Antibody Test

## 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/).