CELL ID PTE LTD · 89-08 · SINGAPORE
For CELL ID 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 Smart Covid-19 Igm/IgG RDT | Quiz SARS-CoV-2 NAT System | Smart Covid-19 Igm/IgG RDT | Smart Covid-19 Igm/IgG RDT | Smart Covid-19 Igm/IgG RDT; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/28/2020; address is 3 Gambas Crescent , Nordcom One , Singapore, SINGAPORE, verified against its source on 2026-09-30.
- Firm
- CELL ID 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 Gambas Crescent , Nordcom One , Singapore, SINGAPORE verified
- Date published
- 10/28/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices each item verified
- Product
- Smart Covid-19 Igm/IgG RDT | Quiz SARS-CoV-2 NAT System | Smart Covid-19 Igm/IgG RDT | Smart Covid-19 Igm/IgG RDT | Smart Covid-19 Igm/IgG RDT each item verified
- FDA notes
- Class III device, requires 510(k), or de novo application | Class III device, requires 510(k), or de novo application | Class III device, requires 510(k), or de novo application | Class III device, requires 510(k), or de novo application each item verified
What the source says
CELL ID PTE LTD Date Published : 10/28/2020 3 Gambas Crescent , Nordcom One , 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, Product and FDA notes
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/28/2020 Desc: Smart Covid-19 Igm/IgG RDT Notes: Class III device, requires 510(k), or de novo application 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/30/2021 Desc: Quiz SARS-CoV-2 NAT System 83 Q - - KO Reagent, coronavirus serological Date Published: 10/28/2020 Desc: Smart Covid-19 Igm/IgG RDT Notes: Class III device, requires 510(k), or de novo application 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/28/2020 Desc: Smart Covid-19 Igm/IgG RDT Notes: Class III device, requires 510(k), or de novo application 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/28/2020 Desc: Smart Covid-19 Igm/IgG RDT Notes: Class III device, requires 510(k), or de novo application
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html