ViroKey® HT Virus Total Nucleic Acid Kit (4x96) 301088

GUDID 08885013958195

The ViroKey® HT Virus Total Nucleic Acid Kit (4x96) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens.

VELA OPERATIONS SINGAPORE PTE. LTD.

Nucleic acid extraction/isolation kit IVD
Primary Device ID08885013958195
NIH Device Record Key28cf8ad3-943b-430d-a13a-f22cdefecf02
Commercial Distribution StatusIn Commercial Distribution
Brand NameViroKey® HT Virus Total Nucleic Acid Kit (4x96)
Version Model Number301088
Catalog Number301088
Company DUNS595361724
Company NameVELA OPERATIONS SINGAPORE PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108885013958195 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-02
Device Publish Date2022-02-22

Devices Manufactured by VELA OPERATIONS SINGAPORE PTE. LTD.

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

Trademark Results [ViroKey]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VIROKEY
VIROKEY
79278674 not registered Live/Pending
Vela Diagnostics Holding Pte. Ltd.
2019-10-14

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