Reference Source

TURKLAB TIBBI MALZEMELER SAN. VE TIC. A.S. · 89-08 · TURKEY

For TURKLAB TIBBI MALZEMELER 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 Toyo SARS-CoV-2 IgM/IgG Ab Test | Info SARS-CoV-2 IgM/IgG Ab Test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 06/22/2022, verified against its source on 2026-09-16.

Firm
TURKLAB TIBBI MALZEMELER 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
Itob Osb Mahallesi , 10017. Sokak No 2 Tekeli - Menderes , Menderes, Izmir TURKEY verified
Date published
06/22/2022 verified
Product code
83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
Product
Toyo SARS-CoV-2 IgM/IgG Ab Test | Info SARS-CoV-2 IgM/IgG Ab 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

TURKLAB TIBBI MALZEMELER SAN. VE TIC. A.S. Date Published : 06/22/2022 Itob Osb Mahallesi , 10017. Sokak No 2 Tekeli - Menderes , Menderes, Izmir TURKEY 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2022 Desc: Toyo SARS-CoV-2 IgM/IgG Ab Test 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2022 Desc: Info SARS-CoV-2 IgM/IgG Ab 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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