# Fujirebio Inc · 89-08 · JAPAN — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 51 Komiya-Cho Hachioji-Shi , Tokyo, JAPAN _(verified: appears in the quote below)_
- **Date published:** 07/27/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** ASAPath COVID-19 Antigen Rapid Test (Kit Ref#10028505) | Lumipulse G SARSCoV-2 Ag-Qual _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).