Reference Source

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. · 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 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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 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

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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