| Primary Device ID | 08885013956399 |
| NIH Device Record Key | e6177b87-6e2f-4ed6-84b7-070e3c835295 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sentosa SQ 318 Chip Kit (8) |
| Version Model Number | 300300 |
| Catalog Number | 300300 |
| Company DUNS | 595361724 |
| Company Name | VELA OPERATIONS SINGAPORE PTE. LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08885013956399 [Primary] |
| PFT | Reagents For Molecular Diagnostic Test Systems |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-21 |
| Device Publish Date | 2020-05-13 |
| 08885013953817 - ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (8x48) | 2022-03-07 ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (8x48) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid f |
| 08885013953855 - ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (4x96) | 2022-03-07 ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (4x96) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid f |
| 08885013958195 - ViroKey® HT Virus Total Nucleic Acid Kit (4x96) | 2022-03-02 The ViroKey® HT Virus Total Nucleic Acid Kit (4x96) is used for magnetic beads-based nucleic acid extraction from virus in biol |
| 08885013956313 - Sentosa ST Template Supplies (8) | 2021-01-27 The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonal ampl |
| 08885013956320 - Sentosa ST Template Reagents (8) | 2021-01-27 The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonal ampl |
| 08885013956337 - Sentosa ST Template Solutions (8) | 2021-01-27 The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonal ampl |
| 08885013956344 - Sentosa ST Template Beads (8) | 2021-01-27 The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonal ampl |
| 08885013956368 - Sentosa SQ Sequencing Supplies (8) | 2021-01-27 The Sentosa SQ Sequencing Kit is used to perform up to 200 base-read sequencing of enriched, template-positive Ion Sphere™ Par |