GUANGZHOU FENGHUA BIOENGINEERING CO.,LTD. · 89-08 · CHINA
For GUANGZHOU FENGHUA BIOENGINEERING 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 SARS-CoV-2 IgM/IgG Combo Rapid Test Kit | SARS-CoV-2 IgM/IgG Combo Rapid Test Kit | SARS-CoV-2 IgM/IgG Combo Rapid Test Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 07/17/2020; address is Guangzhou Economic And Technological , No. 6 Yinyi Street; Development District , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-30.
- Firm
- GUANGZHOU FENGHUA BIOENGINEERING 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
- Guangzhou Economic And Technological , No. 6 Yinyi Street; Development District , Guangzhou, Guangdong CHINA verified
- Date published
- 07/17/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- SARS-CoV-2 IgM/IgG Combo Rapid Test Kit | SARS-CoV-2 IgM/IgG Combo Rapid Test Kit | SARS-CoV-2 IgM/IgG Combo Rapid Test Kit each item verified
What the source says
GUANGZHOU FENGHUA BIOENGINEERING CO.,LTD. Date Published : 07/17/2020 Guangzhou Economic And Technological , No. 6 Yinyi Street; Development District , Guangzhou, 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 - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/17/2020 Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 07/17/2020 Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/17/2020 Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html