DEVICE: Sentosa ST Template Reagents (8) (08885013956320)
Device Identifier (DI) Information
Sentosa ST Template Reagents (8)
300319
In Commercial Distribution
300319
VELA OPERATIONS SINGAPORE PTE. LTD.
300319
In Commercial Distribution
300319
VELA OPERATIONS SINGAPORE PTE. LTD.
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 Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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62173 | Nucleic acid sequencing reagent kit IVD |
A collection of reagents and other associated materials intended to be used on-board a nucleic acid sequencing instrument for the genetic analysis of a clinical specimen. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs). It does not contain analyte-specific reagents and is not intended to be used for whole genome or complementary deoxyribonucleic acid (cDNA) library construction.
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FDA Product Code
[?]Product Code | Product Code Name |
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PFT | Reagents For Molecular Diagnostic Test Systems |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
50f64752-363d-400f-8e4b-267659a3ba5e
January 27, 2021
1
January 19, 2021
January 27, 2021
1
January 19, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined