Lepu Medical Technology (Beijing) Co., Ltd. · 89-08 · CHINA
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
- 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
- No. 37 Chaoqian Rd. , Changping , Changping, Beijing CHINA verified
- Date published
- 05/28/2021 verified
- 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 each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html