SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD · 89-08 · CHINA
For SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD, import alert is 89-08; country is CHINA; 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)"; product is Diazyme SARS-CoV-2 Neutralizing Antibody CLIA kit; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 08/30/2021; address is No. 23 Jinxiu East Road , Longgang District , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING 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. 23 Jinxiu East Road , Longgang District , Shenzhen, Guangdong CHINA verified
- Date published
- 08/30/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- Diazyme SARS-CoV-2 Neutralizing Antibody CLIA kit verified
What the source says
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD Date Published : 08/30/2021 No. 23 Jinxiu East Road , Longgang District , Shenzhen, Guangdong CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
83 Q - - KO Reagent, coronavirus serological Date Published: 08/30/2021 Desc: Diazyme SARS-CoV-2 Neutralizing Antibody CLIA kit
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html