Forefront Medical Technology (Pte) Ltd. · 89-08 · SINGAPORE
For Forefront Medical Technology (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 BioWalker SARS- CoV-2 Assay 2.0; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 09/30/2021; address is 35 Joo Koon Circle , Floor 6th , Singapore, Southwest SINGAPORE, verified against its source on 2026-09-30.
- Firm
- Forefront Medical Technology (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
- 35 Joo Koon Circle , Floor 6th , Singapore, Southwest SINGAPORE verified
- Date published
- 09/30/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- BioWalker SARS- CoV-2 Assay 2.0 verified
What the source says
Forefront Medical Technology (Pte) Ltd. Date Published : 09/30/2021 35 Joo Koon Circle , Floor 6th , Singapore, Southwest 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: BioWalker SARS- CoV-2 Assay 2.0
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html