Reference Source

CHIL TIBBI MAL SAN TIC · 89-08 · TURKEY

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
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
10028 Sok N 11 , Cigli, Izmir TURKEY verified
Date published
08/31/2021 verified
Product code
83 Q - - KO Reagent, coronavirus serological verified
Product
CHIL COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/serum/Plasma) verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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)

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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