Sentosa SQ 318 Chip Kit (8) 300300

GUDID 08885013956399

The Sentosa SQ 318 Chip Kit is used to perform up to 200 base-read sequencing of enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonally amplified DNA.

VELA OPERATIONS SINGAPORE PTE. LTD.

Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD
Primary Device ID08885013956399
NIH Device Record Keye6177b87-6e2f-4ed6-84b7-070e3c835295
Commercial Distribution StatusIn Commercial Distribution
Brand NameSentosa SQ 318 Chip Kit (8)
Version Model Number300300
Catalog Number300300
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108885013956399 [Primary]

FDA Product Code

PFTReagents For Molecular Diagnostic Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

Devices Manufactured by VELA OPERATIONS SINGAPORE PTE. LTD.

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