# Lepu Medical Technology (Beijing) Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Lepu Medical Technology (Beijing) Co., Ltd. · 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 Test | SARS COV 2 Antigen Rapid Test | Corona Virus Test Kit | Corona Virus Reagent Kit | SARS COV2 Antibody Test Colloidal Gold Immunochromatography | SARS-COV-2 ANTIBODY TEST | Lepu Antigen Test; product code is 83 O - - TG Non-sars coronavirus multiplex nucleic acid assay | 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 - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 88 P - - PM General purpose reagent; date published is 05/28/2021; address is No. 37 Chaoqian Rd. , Changping , Changping, Beijing CHINA, verified against its source on 2026-09-16.

- **Firm:** Lepu Medical Technology (Beijing) Co., Ltd. _(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:** No. 37 Chaoqian Rd. , Changping , Changping, Beijing CHINA _(verified: appears in the quote below)_
- **Date published:** 05/28/2021 _(verified: appears in the quote below)_
- **Product code:** 83 O - - TG Non-sars coronavirus multiplex nucleic acid assay | 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 - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 88 P - - PM General purpose reagent _(verified: each item appears in the quote below)_
- **Product:** Covid Test | SARS COV 2 Antigen Rapid Test | Corona Virus Test Kit | Corona Virus Reagent Kit | SARS COV2 Antibody Test Colloidal Gold Immunochromatography | SARS-COV-2 ANTIBODY TEST | Lepu Antigen Test _(verified: each item appears in the quote below)_

## What the source says

> Lepu Medical Technology (Beijing) Co., Ltd. Date Published : 05/28/2021 No. 37 Chaoqian Rd. , Changping , Changping, Beijing CHINA 83 O - - TG Non-sars coronavirus multiplex nucleic acid assay Date Published: 05/28/2021 Desc: Covid Test 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 05/28/2021 Desc: SARS COV 2 Antigen Rapid Test 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 05/28/2021 Desc: Corona Virus Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 05/28/2021 Desc: Corona Virus Reagent Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 05/28/2021 Desc: SARS COV2 Antibody Test Colloidal Gold Immunochromatography 83 Q - - KP Coronavirus antigen detection test system. Date Published: 05/28/2021 Desc: SARS-COV-2 ANTIBODY TEST 88 P - - PM General purpose reagent Date Published: 05/28/2021 Desc: Lepu Antigen 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/).