Autobio Diagnostics Co Ltd · 89-08 · CHINA
For Autobio Diagnostics 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 Anti- SARS-COV-2 Rapid Test | Anti- SARS-COV-2 Rapid Test | Anti- SARS-COV-2 Rapid Test; 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 09/02/2020; address is National Eco &Tech , Development Area , Zhengzhou, Henan CHINA, verified against its source on 2026-09-30.
- Firm
- Autobio Diagnostics 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
- National Eco &Tech , Development Area , Zhengzhou, Henan CHINA verified
- Date published
- 09/02/2020 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
- Anti- SARS-COV-2 Rapid Test | Anti- SARS-COV-2 Rapid Test | Anti- SARS-COV-2 Rapid Test each item verified
What the source says
Autobio Diagnostics Co Ltd Date Published : 09/02/2020 National Eco &Tech , Development Area , Zhengzhou, Henan 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: 09/02/2020 Desc: Anti- SARS-COV-2 Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 09/02/2020 Desc: Anti- SARS-COV-2 Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 09/02/2020 Desc: Anti- SARS-COV-2 Rapid Test
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html