Reference Source

ERKIM ILAC SANAYI · 89-08 · TURKEY

For ERKIM ILAC SANAYI · 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 The ErkimCOVID-19 SARS-CoV-2 iRAMP Diagnostic Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 11/24/2021; address is Koru Sokak No 2 Zorlu C , Istanbul, TURKEY, verified against its source on 2026-09-16.

Firm
ERKIM ILAC SANAYI 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
Koru Sokak No 2 Zorlu C , Istanbul, TURKEY verified
Date published
11/24/2021 verified
Product code
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
Product
The ErkimCOVID-19 SARS-CoV-2 iRAMP Diagnostic Kit verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

ERKIM ILAC SANAYI Date Published : 11/24/2021 Koru Sokak No 2 Zorlu C , Istanbul, TURKEY 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/24/2021 Desc: The ErkimCOVID-19 SARS-CoV-2 iRAMP Diagnostic Kit

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

Source

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