Reference Source

AIBIOTECH PTE LTD · 89-08 · SINGAPORE

For AIBIOTECH PTE LTD, import alert is 89-08; country is SINGAPORE; 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 abTES%u2122 COVID-19 qPCR Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 09/30/2021; address is 25 Pandan Crescent , Tic Tech Centre , Singapore, SINGAPORE, verified against its source on 2026-09-30.

Firm
AIBIOTECH PTE LTD 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
SINGAPORE verified
Address
25 Pandan Crescent , Tic Tech Centre , Singapore, SINGAPORE verified
Date published
09/30/2021 verified
Product code
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
Product
abTES%u2122 COVID-19 qPCR Kit verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

AIBIOTECH PTE LTD Date Published : 09/30/2021 25 Pandan Crescent , Tic Tech Centre , Singapore, SINGAPORE

— 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: 09/30/2021 Desc: abTES%u2122 COVID-19 qPCR 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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