Shenzhen Cas-Envision Medical Technology Co., Ltd. · 89-08 · CHINA
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
- 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
- Bldg# F/4 , 4 Qidixiexin Science Park, No.333 Longfei Ave, Longcheng St; Longgang District , Shenzhen, Guangdong CHINA verified
- Date published
- 04/05/2022 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. | 88 P - - PM General purpose reagent each item verified
- Product
- SARS-CoV-2 Antigen Rapid Detection Kit | SARS-CoV-2 Antigen Rapid Detection Kit each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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