MICOBIOMED CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF)
For MICOBIOMED 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 Veri-Q COVID-19 Multiplex Assay Kits | Kairogen covid-19 antigen rapid test | VERI-Q COVID-19 Ag Rapid Test; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/08/2022; address is 54 3, 4th Floor , Seongnam , Changeop-Ro, Sujeong, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- MICOBIOMED 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
- 54 3, 4th Floor , Seongnam , Changeop-Ro, Sujeong, KOREA (THE REPUBLIC OF) verified
- Date published
- 06/08/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- Veri-Q COVID-19 Multiplex Assay Kits | Kairogen covid-19 antigen rapid test | VERI-Q COVID-19 Ag Rapid Test each item verified
What the source says
MICOBIOMED CO., LTD. Date Published : 06/08/2022 54 3, 4th Floor , Seongnam , Changeop-Ro, Sujeong, KOREA (THE REPUBLIC OF) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/08/2022 Desc: Veri-Q COVID-19 Multiplex Assay Kits 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/08/2022 Desc: Kairogen covid-19 antigen rapid test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/08/2022 Desc: VERI-Q COVID-19 Ag Rapid Test
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html