ONCOSEM ONKOLOJIK SISTEMLER SAN.VE TIC. A.S · 89-08 · TURKEY
For ONCOSEM ONKOLOJIK SISTEMLER SAN.VE TIC. A.S · 89-08 · TURKEY, 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 TURKEY; product is CRT (COVID-19 RAPID TEST) | CRT (COVID-19 RAPID TEST) | CRT (COVID-19 RAPID TEST) | CRT (COVID-19 RAPID TEST); product code is 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 - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/21/2020; address is Mustafa Kemal Mah. Kolbay Is Merkezi A Blok No:6/8 Cankaya , Ankara, TURKEY, verified against its source on 2026-09-16.
- Firm
- ONCOSEM ONKOLOJIK SISTEMLER SAN.VE TIC. A.S 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
- TURKEY verified
- Address
- Mustafa Kemal Mah. Kolbay Is Merkezi A Blok No:6/8 Cankaya , Ankara, TURKEY verified
- Date published
- 10/21/2020 verified
- Product code
- 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 - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices each item verified
- Product
- CRT (COVID-19 RAPID TEST) | CRT (COVID-19 RAPID TEST) | CRT (COVID-19 RAPID TEST) | CRT (COVID-19 RAPID TEST) each item verified
What the source says
ONCOSEM ONKOLOJIK SISTEMLER SAN.VE TIC. A.S Date Published : 10/21/2020 Mustafa Kemal Mah. Kolbay Is Merkezi A Blok No:6/8 Cankaya , Ankara, TURKEY 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/21/2020 Desc: CRT (COVID-19 RAPID TEST) 83 Q - - KO Reagent, coronavirus serological Date Published: 10/21/2020 Desc: CRT (COVID-19 RAPID TEST) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/21/2020 Desc: CRT (COVID-19 RAPID TEST) 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/21/2020 Desc: CRT (COVID-19 RAPID TEST)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html