Primary Device ID | 08885013958195 |
NIH Device Record Key | 28cf8ad3-943b-430d-a13a-f22cdefecf02 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ViroKey® HT Virus Total Nucleic Acid Kit (4x96) |
Version Model Number | 301088 |
Catalog Number | 301088 |
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 | false |
Expiration Date | true |
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 | 08885013958195 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-03-02 |
Device Publish Date | 2022-02-22 |
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) | 2022-03-02The ViroKey® HT Virus Total Nucleic Acid Kit (4x96) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens. |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VIROKEY 79278674 not registered Live/Pending |
Vela Diagnostics Holding Pte. Ltd. 2019-10-14 |