AMT PTE. LTD. · 89-08 · SINGAPORE
For AMT 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 RESOLUTE 2.0 SARS-CoV-2 Detection Assay; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 09/30/2021; address is 3 Tuas Lane , Singapore, South West SINGAPORE, verified against its source on 2026-09-30.
- Firm
- AMT 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
- 3 Tuas Lane , Singapore, South West SINGAPORE verified
- Date published
- 09/30/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- RESOLUTE 2.0 SARS-CoV-2 Detection Assay verified
What the source says
AMT PTE. LTD. Date Published : 09/30/2021 3 Tuas Lane , Singapore, South West 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: RESOLUTE 2.0 SARS-CoV-2 Detection Assay
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.