CANCERROP · 89-08 · KOREA (THE REPUBLIC OF)
For CANCERROP · 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 IgM/IgG Combo Rapid Test Kit | SARS-CoV-2 IgM/IgG Combo Rapid Test Kit | SARS-CoV-2 IgM/IgG Combo Rapid Test Kit; 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 07/17/2020; address is 10f Elysia Bldg 173 , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- CANCERROP 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
- 10f Elysia Bldg 173 , Seoul, KOREA (THE REPUBLIC OF) verified
- Date published
- 07/17/2020 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
- SARS-CoV-2 IgM/IgG Combo Rapid Test Kit | SARS-CoV-2 IgM/IgG Combo Rapid Test Kit | SARS-CoV-2 IgM/IgG Combo Rapid Test Kit each item verified
What the source says
CANCERROP Date Published : 07/17/2020 10f Elysia Bldg 173 , Seoul, KOREA (THE REPUBLIC OF) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/17/2020 Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 07/17/2020 Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/17/2020 Desc: SARS-CoV-2 IgM/IgG Combo Rapid Test Kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html