MICOBIOMED CO., LTD. · 89-08 · KOREA (THE REPUBLIC OF)
For MICOBIOMED 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 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 2026-09-30.
- 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)
— 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 - - 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html