AccessGUDID - DEVICE: Sentosa SX IA Reactions Kit (4) (08885013956511)

GUDID

Device Identifier (DI) Information

Brand Name: Sentosa SX IA Reactions Kit (4)
Version or Model: 300733
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 300733
Company Name: VELA OPERATIONS SINGAPORE PTE. LTD.

Primary DI Number: 08885013956511
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595361724 *Terms of Use

Device Description: The Sentosa SX IA Template Prep Kit is intended for isothermal template preparation after library preparation is complete. it is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonally amplified DNA for up to 200 base-read sequencing of a library. The Sentosa SX IA Template Prep Kit is comprised of three components; the Sentosa SX IA Reactions Kit, the Sentosa SX IA Reagents Kit and the Sentosa SX IA Solutions Kit.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFT	Reagents For Molecular Diagnostic Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad36fcee-ba39-4d28-86b2-951dd563c167
Public Version Date: January 27, 2021
Public Version Number: 1
DI Record Publish Date: January 19, 2021