Reference Source

DOWGENE DNA TESTING COMPANY · 89-08 · KOREA (THE REPUBLIC OF)

For DOWGENE DNA TESTING COMPANY, import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 Dow QuickFinder 2019-nCoV Real-Time PCR kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 06/08/2022; address is Rm 513 Ace High End Tow , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.

Firm
DOWGENE DNA TESTING COMPANY 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
KOREA (THE REPUBLIC OF) verified
Address
Rm 513 Ace High End Tow , Seoul, KOREA (THE REPUBLIC OF) verified
Date published
06/08/2022 verified
Product code
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
Product
Dow QuickFinder 2019-nCoV Real-Time PCR kit verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

DOWGENE DNA TESTING COMPANY Date Published : 06/08/2022 Rm 513 Ace High End Tow , Seoul, KOREA (THE REPUBLIC OF)

— 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 - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/08/2022 Desc: Dow QuickFinder 2019-nCoV Real-Time PCR kit

— 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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