Innovita (Tangshan) Biological Technology Co., Ltd. · 89-08 · CHINA
For Innovita (Tangshan) Biological Technology 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 Scanwell SARS-CoV-2 IgM & IgG Test System | Innovita 2019-nCoV Ag Test (Latex Chromatography Assay); product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2021; address is No.699 Juxin Street,High-tech Industrial Development Zone , Qian'An, Hebei CHINA, verified against its source on 2026-09-16.
- Firm
- Innovita (Tangshan) Biological Technology 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
- No.699 Juxin Street,High-tech Industrial Development Zone , Qian'An, Hebei CHINA verified
- Date published
- 06/22/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- Scanwell SARS-CoV-2 IgM & IgG Test System | Innovita 2019-nCoV Ag Test (Latex Chromatography Assay) each item verified
What the source says
Innovita (Tangshan) Biological Technology Co., Ltd. Date Published : 06/22/2021 No.699 Juxin Street,High-tech Industrial Development Zone , Qian'An, Hebei CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 08/30/2021 Desc: Scanwell SARS-CoV-2 IgM & IgG Test System 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: Innovita 2019-nCoV Ag Test (Latex Chromatography Assay)
— 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.