SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION · 89-08 · JAPAN
For SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, 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 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
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 - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 01/06/2022 Desc: 2019 Novel Coronavirus Detection Kit
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html