# CHIL TIBBI MAL SAN TIC · 89-08 · TURKEY — FDA import alert red lists: firms subject to detention without physical examination

For CHIL TIBBI MAL SAN TIC · 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 CHIL COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/serum/Plasma); product code is 83 Q - - KO Reagent, coronavirus serological; date published is 08/31/2021; address is 10028 Sok N 11 , Cigli, Izmir TURKEY, verified against its source on 2026-09-16.

- **Firm:** CHIL TIBBI MAL SAN TIC _(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:** 10028 Sok N 11 , Cigli, Izmir TURKEY _(verified: appears in the quote below)_
- **Date published:** 08/31/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological _(verified: appears in the quote below)_
- **Product:** CHIL COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/serum/Plasma) _(verified: appears in the quote below)_

## What the source says

> CHIL TIBBI MAL SAN TIC Date Published : 08/31/2021 10028 Sok N 11 , Cigli, Izmir TURKEY 83 Q - - KO Reagent, coronavirus serological Date Published: 08/31/2021 Desc: CHIL COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/serum/Plasma)

## 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/).