Reference Source

Celestica Electronics (M) Sdn Bhd-( · 89-08 · MALAYSIA

For Celestica Electronics (M) Sdn Bhd-(, import alert is 89-08; country is MALAYSIA; 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 Pelican COVID-19 Ultra-Rapid Mobile Test for At-Home Testing; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 04/01/2022; address is Lot 1 , Air Port Logistics Parksenai Intl , Senai, Johor MALAYSIA, verified against its source on 2026-09-30.

Firm
Celestica Electronics (M) Sdn Bhd-( 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
MALAYSIA verified
Address
Lot 1 , Air Port Logistics Parksenai Intl , Senai, Johor MALAYSIA verified
Date published
04/01/2022 verified
Product code
83 Q - - KP Coronavirus antigen detection test system. verified
Product
Pelican COVID-19 Ultra-Rapid Mobile Test for At-Home Testing verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Celestica Electronics (M) Sdn Bhd-( Date Published : 04/01/2022 Lot 1 , Air Port Logistics Parksenai Intl , Senai, Johor MALAYSIA

— 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 - - KP Coronavirus antigen detection test system. Date Published: 04/01/2022 Desc: Pelican COVID-19 Ultra-Rapid Mobile Test for At-Home Testing

— 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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