GENOMICTREE · 89-08 · KOREA (THE REPUBLIC OF)
For GENOMICTREE · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) | SARS-CoV-2 Real-TM | AccuraDTect SARS-CoV-2 RT-qPCR Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 11/29/2022; address is 44-6 Techno 10-Ro , Daejon , Yuseong, Daejeon Gwangyeogsi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- GENOMICTREE 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
- KOREA (THE REPUBLIC OF) verified
- Address
- 44-6 Techno 10-Ro , Daejon , Yuseong, Daejeon Gwangyeogsi KOREA (THE REPUBLIC OF) verified
- Date published
- 11/29/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid each item verified
- Product
- StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) | SARS-CoV-2 Real-TM | AccuraDTect SARS-CoV-2 RT-qPCR Kit each item verified
What the source says
GENOMICTREE Date Published : 11/29/2022 44-6 Techno 10-Ro , Daejon , Yuseong, Daejeon Gwangyeogsi KOREA (THE REPUBLIC OF) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/29/2022 Desc: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/29/2022 Desc: SARS-CoV-2 Real-TM 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/29/2022 Desc: AccuraDTect SARS-CoV-2 RT-qPCR Kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html