Humasis Co Ltd · 89-08 · KOREA (THE REPUBLIC OF)
For Humasis Co Ltd, import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 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 2026-09-30.
- 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)
— 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 - - KO Reagent, coronavirus serological Date Published: 04/20/2022 Desc: SARS-CoV-2 IgG/IgM Antibody Test
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html