Fujirebio Inc · 89-08 · JAPAN
For Fujirebio Inc, import alert is 89-08; country is JAPAN; 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 Lumipulse G SARSCoV-2 Ag-Qual | ASAPath COVID-19 Antigen Rapid Test (Kit Ref#10028505); product code is 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 07/27/2021; address is 51 Komiya-Cho Hachioji-Shi , Tokyo, JAPAN, verified against its source on 2026-09-30.
- Firm
- Fujirebio Inc 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
- JAPAN verified
- Address
- 51 Komiya-Cho Hachioji-Shi , Tokyo, JAPAN verified
- Date published
- 07/27/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- Lumipulse G SARSCoV-2 Ag-Qual | ASAPath COVID-19 Antigen Rapid Test (Kit Ref#10028505) each item verified
What the source says
Fujirebio Inc Date Published : 07/27/2021 51 Komiya-Cho Hachioji-Shi , Tokyo, JAPAN
— accessdata.fda.gov, retrieved 2026-09-22
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 - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: Lumipulse G SARSCoV-2 Ag-Qual 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: ASAPath COVID-19 Antigen Rapid Test (Kit Ref#10028505)
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html