# Shenzhen Cas-Envision Medical Technology Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shenzhen Cas-Envision Medical Technology 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 SARS-CoV-2 Antigen Rapid Detection Kit | SARS-CoV-2 Antigen Rapid Detection Kit; product code is 83 Q - - KP Coronavirus antigen detection test system. | 88 P - - PM General purpose reagent; date published is 04/05/2022; address is Bldg# F/4 , 4 Qidixiexin Science Park, No.333 Longfei Ave, Longcheng St; Longgang District , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Shenzhen Cas-Envision Medical Technology 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:** Bldg# F/4 , 4 Qidixiexin Science Park, No.333 Longfei Ave, Longcheng St; Longgang District , Shenzhen, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 04/05/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. | 88 P - - PM General purpose reagent _(verified: each item appears in the quote below)_
- **Product:** SARS-CoV-2 Antigen Rapid Detection Kit | SARS-CoV-2 Antigen Rapid Detection Kit _(verified: each item appears in the quote below)_

## What the source says

> Shenzhen Cas-Envision Medical Technology Co., Ltd. Date Published : 04/05/2022 Bldg# F/4 , 4 Qidixiexin Science Park, No.333 Longfei Ave, Longcheng St; Longgang District , Shenzhen, Guangdong CHINA 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/05/2022 Desc: SARS-CoV-2 Antigen Rapid Detection Kit 88 P - - PM General purpose reagent Date Published: 04/05/2022 Desc: SARS-CoV-2 Antigen Rapid Detection Kit

## 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/).