Absology Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For Absology 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 Absoludy COVID-19 IgM/IgG Combo | Absoludy COVID-19 IgM/IgG Rapid | INIST COVID-19 IgM/IgG Rapid; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 01/26/2021; address is Simin-Daero 383, Dongan , # 1303 Digital Empire "B" , Anyang, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Absology 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
- Simin-Daero 383, Dongan , # 1303 Digital Empire "B" , Anyang, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 01/26/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- Absoludy COVID-19 IgM/IgG Combo | Absoludy COVID-19 IgM/IgG Rapid | INIST COVID-19 IgM/IgG Rapid each item verified
What the source says
Absology Co., Ltd. Date Published : 01/26/2021 Simin-Daero 383, Dongan , # 1303 Digital Empire "B" , Anyang, Gyeonggi KOREA (THE REPUBLIC OF) 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: Absoludy COVID-19 IgM/IgG Combo 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: Absoludy COVID-19 IgM/IgG Rapid 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: INIST COVID-19 IgM/IgG Rapid
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html