Z Biotech Inc. · 89-08 · KOREA (THE REPUBLIC OF)
For Z Biotech 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 RAPID TEST KIT | COVID-19 Ag RDT Test Kit | ANW COVID-19 Ag RDT Test Kit; product code is 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 07/27/2021; address is #1409, 134, Gongdan-Ro , Heungdeok-Gu , Cheongju-Si, Chungcheongbuk-do KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Z Biotech 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
- #1409, 134, Gongdan-Ro , Heungdeok-Gu , Cheongju-Si, Chungcheongbuk-do KOREA (THE REPUBLIC OF) verified
- Date published
- 07/27/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- RAPID TEST KIT | COVID-19 Ag RDT Test Kit | ANW COVID-19 Ag RDT Test Kit each item verified
What the source says
Z Biotech Inc. Date Published : 07/27/2021 #1409, 134, Gongdan-Ro , Heungdeok-Gu , Cheongju-Si, Chungcheongbuk-do KOREA (THE REPUBLIC OF) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: RAPID TEST KIT 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: COVID-19 Ag RDT Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: ANW COVID-19 Ag RDT Test Kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html