RTA LABORATUVARLARI BIYOLOJIK Urunler Ilac Ve Makine San Tic A.S. · 89-08 · TURKEY
For RTA LABORATUVARLARI BIYOLOJIK Urunler Ilac Ve Makine San Tic A.S., import alert is 89-08; country is TURKEY; 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 Cirrus COVID-19IgM/IgG Antibody Test | Cirrus Serological IgGand IgM Test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 05/14/2021; address is Plastikciler Organized Industrial Zone (Geposb) Cumhuriye , Gebze, Kocaeli TURKEY, verified against its source on 2026-09-30.
- Firm
- RTA LABORATUVARLARI BIYOLOJIK Urunler Ilac Ve Makine San 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
- Plastikciler Organized Industrial Zone (Geposb) Cumhuriye , Gebze, Kocaeli TURKEY verified
- Date published
- 05/14/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- Cirrus COVID-19IgM/IgG Antibody Test | Cirrus Serological IgGand IgM Test each item verified
What the source says
RTA LABORATUVARLARI BIYOLOJIK Urunler Ilac Ve Makine San Tic A.S. Date Published : 05/14/2021 Plastikciler Organized Industrial Zone (Geposb) Cumhuriye , Gebze, Kocaeli TURKEY
— 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 - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: Cirrus COVID-19IgM/IgG Antibody Test 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: Cirrus Serological IgGand IgM Test
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html