SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · 89-08 · JAPAN
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
- 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
- Nishinokyo Kuwabara -Cho , Nakagyo-Ku; 1 , Kyoto, Kyoto JAPAN verified
- Date published
- 01/06/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- 2019 Novel Coronavirus Detection Kit verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.