Humasis Co Ltd · 89-08 · KOREA (THE REPUBLIC OF)
For Humasis Co Ltd · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is SARS-CoV-2 IgG/IgM Antibody Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 04/20/2022; address is Rm.114,502,504,604-1,B03-01,B03-02,88 , Jeonpa-Ro,Dongan-Gu , Anyang-Si, GYEONGGIDO KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Humasis 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
- KOREA (THE REPUBLIC OF) verified
- Address
- Rm.114,502,504,604-1,B03-01,B03-02,88 , Jeonpa-Ro,Dongan-Gu , Anyang-Si, GYEONGGIDO KOREA (THE REPUBLIC OF) verified
- Date published
- 04/20/2022 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- SARS-CoV-2 IgG/IgM Antibody Test verified
What the source says
Humasis Co Ltd Date Published : 04/20/2022 Rm.114,502,504,604-1,B03-01,B03-02,88 , Jeonpa-Ro,Dongan-Gu , Anyang-Si, GYEONGGIDO KOREA (THE REPUBLIC OF) 83 Q - - KO Reagent, coronavirus serological Date Published: 04/20/2022 Desc: SARS-CoV-2 IgG/IgM Antibody Test
— 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.