# TURKLAB TIBBI MALZEMELER SAN. VE TIC. A.S. · 89-08 · TURKEY — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Itob Osb Mahallesi , 10017. Sokak No 2 Tekeli - Menderes , Menderes, Izmir TURKEY _(verified: appears in the quote below)_
- **Date published:** 06/22/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological _(verified: each item appears in the quote below)_
- **Product:** Toyo SARS-CoV-2 IgM/IgG Ab Test | Info SARS-CoV-2 IgM/IgG Ab Test _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).