Boditech Med, Inc. · 89-08 · KOREA (THE REPUBLIC OF)
For Boditech Med, Inc. · 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 Ichroma COVID-19 Ab (with ichroma II analyzer) | ExAmplar COVID-19 real-time PCR kit (L) | Ichroma COVID-19 Ab (with ichroma II analyzer) | Ichroma COVID-19 Ab (with ichroma II analyzer) | AFIAS COVID-19 Ag (with AFIAS- 6 Analyzer) | Ichroma COVID-19 Ab (with ichroma II analyzer); product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/19/2020; address is 43 Geodudanji1-Gil , Dongnae-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Boditech Med, Inc. 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
- 43 Geodudanji1-Gil , Dongnae-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF) verified
- Date published
- 10/19/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices each item verified
- Product
- Ichroma COVID-19 Ab (with ichroma II analyzer) | ExAmplar COVID-19 real-time PCR kit (L) | Ichroma COVID-19 Ab (with ichroma II analyzer) | Ichroma COVID-19 Ab (with ichroma II analyzer) | AFIAS COVID-19 Ag (with AFIAS- 6 Analyzer) | Ichroma COVID-19 Ab (with ichroma II analyzer) each item verified
What the source says
Boditech Med, Inc. Date Published : 10/19/2020 43 Geodudanji1-Gil , Dongnae-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/19/2020 Desc: Ichroma COVID-19 Ab (with ichroma II analyzer) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/07/2021 Desc: ExAmplar COVID-19 real-time PCR kit (L) 83 Q - - KO Reagent, coronavirus serological Date Published: 10/19/2020 Desc: Ichroma COVID-19 Ab (with ichroma II analyzer) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/19/2020 Desc: Ichroma COVID-19 Ab (with ichroma II analyzer) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/04/2022 Desc: AFIAS COVID-19 Ag (with AFIAS- 6 Analyzer) 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/19/2020 Desc: Ichroma COVID-19 Ab (with ichroma II analyzer)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html