Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) 300395

GUDID 08885013958171

The Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens. The kit is intended for in vitro diagnostic use.

VELA OPERATIONS SINGAPORE PTE. LTD.

Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD
Primary Device ID08885013958171
NIH Device Record Keyd5a0c636-1812-454a-a719-c164b653d216
Commercial Distribution StatusIn Commercial Distribution
Brand NameSentosa SX Virus Total Nucleic Acid Plus Kit (4x24)
Version Model Number300395
Catalog Number300395
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
GS108885013958171 [Primary]
GS108885013958171 [Primary]
GS108885013958171 [Primary]
GS108885013958171 [Primary]

FDA Product Code

JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator
JJHClinical Sample Concentrator

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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08885013956399 - Sentosa SQ 318 Chip Kit (8)2020-05-21 The Sentosa SQ 318 Chip Kit is used to perform up to 200 base-read sequencing of enriched, template-positive Ion Sphere™ Parti
08885013958157 - Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24)2020-05-21 The Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) is used for magnetic beads-based nucleic acid extraction from virus in b
08885013958171 - Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)2020-05-21The Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens. The kit is intended for in vitro diagnostic use.
08885013958171 - Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)2020-05-21 The Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) is used for magnetic beads-based nucleic acid extraction from virus in b

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