Reference Source

CHIL TIBBI MAL SAN TIC · 89-08 · TURKEY

For CHIL TIBBI MAL SAN TIC, import alert is 89-08; country is TURKEY; 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)"; 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 2026-09-30.

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

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

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code and Product

83 Q - - KO Reagent, coronavirus serological Date Published: 08/31/2021 Desc: CHIL COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/serum/Plasma)

— all from 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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