Fujirebio Inc · 89-08 · JAPAN
For Fujirebio Inc · 89-08 · JAPAN, 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 JAPAN; product is ASAPath COVID-19 Antigen Rapid Test (Kit Ref#10028505) | Lumipulse G SARSCoV-2 Ag-Qual; 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 2026-09-16.
- 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
- ASAPath COVID-19 Antigen Rapid Test (Kit Ref#10028505) | Lumipulse G SARSCoV-2 Ag-Qual each item verified
What the source says
Fujirebio Inc Date Published : 07/27/2021 51 Komiya-Cho Hachioji-Shi , Tokyo, JAPAN 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: ASAPath COVID-19 Antigen Rapid Test (Kit Ref#10028505) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: Lumipulse G SARSCoV-2 Ag-Qual
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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