# SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · 89-08 · JAPAN — FDA import alert red lists: firms subject to detention without physical examination

For SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · 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 2019 Novel Coronavirus Detection Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 01/06/2022; address is Nishinokyo Kuwabara -Cho , Nakagyo-Ku; 1 , Kyoto, Kyoto JAPAN, verified against its source on 2026-09-16.

- **Firm:** SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION _(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:** Nishinokyo Kuwabara -Cho , Nakagyo-Ku; 1 , Kyoto, Kyoto JAPAN _(verified: appears in the quote below)_
- **Date published:** 01/06/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: appears in the quote below)_
- **Product:** 2019 Novel Coronavirus Detection Kit _(verified: appears in the quote below)_

## What the source says

> SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Date Published : 01/06/2022 Nishinokyo Kuwabara -Cho , Nakagyo-Ku; 1 , Kyoto, Kyoto JAPAN 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 01/06/2022 Desc: 2019 Novel Coronavirus Detection Kit

## 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/).