VELA OPERATIONS SINGAPORE PTE. LTD.

Address:50 Science Park Road,Singapore Central Singapore,SG

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- Catalog Number : 400089

Device Description : Sentosa SX101 is an automated pipetting instrument designed for contamination-fr Sentosa SX101 is an automated pipetting instrument designed for contamination-free, precise and correct measuring and transferring of liquids.

Device Class : 1

Duns Number: 595361724

Premarket Exempt : Yes

Product Code : JQW

Prescription Use : No

Device Count : 1

Device Description : The Sentosa SA201 Real-Time PCR Instrument is a real-time nucleic acid amplifica The Sentosa SA201 Real-Time PCR Instrument is a real-time nucleic acid amplification and detection system. It measures nucleic acid signals from reverse transcribed RNA and converts the signals to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes.

Device Class : 2

Duns Number: 595361724

Premarket Exempt : Yes

Product Code : OOI

Prescription Use : No

Device Count : 1

Device Description : The Sentosa® SQ301 Platform is an in vitro diagnostic system composed of a seque The Sentosa® SQ301 Platform is an in vitro diagnostic system composed of a sequencing instrument that measures the hydrogen ions that are generated during the incorporation of nucleotides in the DNA sequencing reaction and the ancillary instrumentation necessary for sample processing. This platform is used in conjunction with instrument-specific library preparation kits, template kits, sequencing kits, chip kits and data analysis software. The Sentosa® SQ301 Platform is intended for targeted sequencing of various biological samples. The Sentosa® SQ301 Platform is not intended for whole genome or de novo sequencing.

Device Class : 2

Duns Number: 595361724

Premarket Exempt : Yes

Product Code : PFF

Prescription Use : No

Device Count : 1

- Catalog Number : 400124

Device Description : Sentosa ST401i is used for emulsion PCR and forms part of SQ301 Platform.

Device Class : 2

Duns Number: 595361724

Premarket Exempt : Yes

Product Code : PFF

Prescription Use : No

Device Count : 1

- Catalog Number : 400120

Device Description : ST401e is used for enrichment and forms part of SQ301 Platform.

Device Class : 2

Duns Number: 595361724

Premarket Exempt : Yes

Product Code : PFF

Prescription Use : No

Device Count : 1

Device Description : Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR based in vitro diagnostic test Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR based in vitro diagnostic test to detect and differentiate HSV1 and HSV2 virus DNA qualitatively.

Device Class : 2

Duns Number: 595361724

Premarket Exempt : No

Product Code : OQO

Prescription Use : No

Device Count : 1

Device Description : ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (8x48) is a real-time RT-PCR test intended 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 from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal or nasopharyngeal aspirates, nasal washes and bronchoalveolar lavage samples collected from individuals suspected of COVID-19 by their healthcare provider.Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

Device Class :

Duns Number: 595361724

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Device Description : ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (4x96) is a real-time RT-PCR test intended 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 from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal or nasopharyngeal aspirates, nasal washes and bronchoalveolar lavage samples collected from individuals suspected of COVID-19 by their healthcare provider.Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

Device Class :

Duns Number: 595361724

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Device Description : The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion S The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonal amplified DNA for up to 200 base-read sequencing of a library.Sentosa ST Template Kit is comprised of four components; Sentosa ST Template Supplies, Sentosa ST Template Solutions, Sentosa ST Template Reagents and Sentosa ST Template Beads.

Device Class : 1

Duns Number: 595361724

Premarket Exempt : Yes

Product Code : PFT

Prescription Use : No

Device Count : 1

Device Description : The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion S The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonal amplified DNA for up to 200 base-read sequencing of a library.Sentosa ST Template Kit is comprised of four components; Sentosa ST Template Supplies, Sentosa ST Template Solutions, Sentosa ST Template Reagents and Sentosa ST Template Beads.

Device Class : 1

Duns Number: 595361724

Premarket Exempt : Yes

Product Code : PFT

Prescription Use : No

Device Count : 1