SINGUWAY BIOTECH INC · 89-08 · CHINA (Room 306, No. 15 Bldg , Guangdong, CHINA)
For SINGUWAY BIOTECH INC (Room 306, No. 15 Bldg , Guangdong, CHINA), 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 Singuway COVID-19 Test Kit | COVID-19 IgG/IgM Detection Kit (Colloidal Gold); 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 2026-09-30.
- 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
- Singuway COVID-19 Test Kit | COVID-19 IgG/IgM Detection Kit (Colloidal Gold) each item verified
What the source says
SINGUWAY BIOTECH INC Date Published : 01/26/2021 Room 306, No. 15 Bldg , Guangdong, CHINA
— accessdata.fda.gov, retrieved 2026-09-22
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: 01/26/2021 Desc: Singuway COVID-19 Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: COVID-19 IgG/IgM Detection Kit (Colloidal Gold)
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html