Guangdong Ardent Biomed Co., Ltd · 89-08 · CHINA
For Guangdong Ardent Biomed 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 Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit(PCR fluorescent Probe); product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 06/08/2022; address is High-Tech Industrial 4th Floor , Of C1 Building,No.11 Kaiyuan Road Science City; Development District , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- Guangdong Ardent Biomed 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
- High-Tech Industrial 4th Floor , Of C1 Building,No.11 Kaiyuan Road Science City; Development District , Guangzhou, Guangdong CHINA verified
- Date published
- 06/08/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit(PCR fluorescent Probe) verified
What the source says
Guangdong Ardent Biomed Co., Ltd Date Published : 06/08/2022 High-Tech Industrial 4th Floor , Of C1 Building,No.11 Kaiyuan Road Science City; Development District , Guangzhou, Guangdong CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/08/2022 Desc: Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit(PCR fluorescent Probe)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.