TURKLAB TIBBI MALZEMELER SAN. VE TIC. A.S. · 89-08 · TURKEY
For TURKLAB TIBBI MALZEMELER SAN. VE TIC. A.S., 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 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 2026-09-30.
- Firm
- TURKLAB TIBBI MALZEMELER SAN. VE TIC. A.S. 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
- Itob Osb Mahallesi , 10017. Sokak No 2 Tekeli - Menderes , Menderes, Izmir TURKEY verified
- Date published
- 06/22/2022 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- Toyo SARS-CoV-2 IgM/IgG Ab Test | Info SARS-CoV-2 IgM/IgG Ab Test each item verified
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
— 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: 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html