SINGUWAY BIOTECH INC · 89-08 · CHINA
For SINGUWAY BIOTECH INC · 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-19 IgG/IgM Detection Kit (Colloidal Gold) | Singuway COVID-19 Test Kit; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 01/26/2021; address is Room 306, No. 15 Bldg , Guangdong, CHINA, verified against its source on 2026-09-16.
- Firm
- SINGUWAY BIOTECH INC 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
- Room 306, No. 15 Bldg , Guangdong, CHINA verified
- Date published
- 01/26/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Singuway COVID-19 Test Kit each item verified
What the source says
SINGUWAY BIOTECH INC Date Published : 01/26/2021 Room 306, No. 15 Bldg , Guangdong, CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: Singuway COVID-19 Test Kit
— 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.