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
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
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.