Home GUDID 00816270020019 MiSeqDx CF 139 Variant Assay (2 Run)
Primary DI 00816270020019
Brand MiSeqDx CF 139 Variant Assay (2 Run)
Company ILLUMINA, INC.
Model 15036580
Catalog number DX-102-1004
Device description The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis 139 Variant Assay (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier:15041293 MiSeqDx Cystic Fibrosis 139 Variant Assay 1/515041291 MiSeqDx Cystic Fibrosis 139 Variant Assay 1A15041292 MiSeqDx Cystic Fibrosis 139 Variant Assay 1B15041294 MiSeqDx Cystic Fibrosis 139 Variant Assay 2/515041297 MiSeqDx Cystic Fibrosis 139 Variant Assay 3/515041295 MiSeqDx Cystic Fibrosis 139 Variant Assay 3A15041296 MiSeqDx Cystic Fibrosis 139 Variant Assay 3B15041298 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 4/515041299 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 5/5
Published 2016-09-21
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name PFR System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PFR System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816270020019 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816270020019 00816270020019 816270020019 0816270020019
GMDN Terms# Term, Definition table Term Definition Cystic fibrosis IVD, kit, multiplex A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple mutations associated with the inborn genetic disorder cystic fibrosis due to mutation in the cystic fibrosis conductance regulator (CFTR) gene, using a multiplex method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius Storage Environment Temperature 15 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 033305264 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00816270020415 Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx 20063024 20063024 2022-11-07 00816270020330 DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx 20074730 2026-04-27 00816270020217 TruSight™ Oncology Comprehensive 20032573 2024-12-09 00816270020644 TruSight™ Oncology RNA Control 20065042 2024-12-09 00816270020651 TruSight™ Oncology DNA Control IVD 20065041 2024-12-09 00816270020088 Praxis Extended RAS Panel 20012431 20012431 2017-08-28 00816270020262 Local Run Manager CF Clinical Sequencing Analysis Module 20046734 20046734 2023-06-15 00816270020286 Local Run Manager CF 139 Variant Analysis Module 20047009 20047009 2023-06-15 00816270020378 Local Run Manager CF 139-Variant 2.0 Micro Analysis Module 20072975 20072975 2023-06-15 00816270020385 Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module 20072974 20072974 2023-06-15 00816270020149 TruSight™ Cystic Fibrosis Library Preparation 20036925 20036925 2020-04-09 00816270020026 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run) 15036620 DX-102-1001 2016-09-21 00816270020033 MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run) 15036577 DX-102-1003 2017-08-14 00816270020392 Local Run Manager DNA GenerateFASTQ Dx Module for MiSeq™Dx 20063022 20063022 2022-11-07 00816270020743 DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx 20074609 20074609 2022-11-07 00816270020453 Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples) 20051352 20051352 2022-10-20 00816270020460 Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (96 samples) 20051353 20051353 2022-10-20 00816270020477 Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (16 samples) 20051354 20051354 2022-10-20 00816270020484 Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (16 samples) 20051355 20051355 2022-10-20 00816270020538 NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles) 20046931 20046931 2022-10-18
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00816270020286 Local Run Manager CF 139 Variant Analysis Module ILLUMINA, INC. PFR 2023-06-15 00816270020378 Local Run Manager CF 139-Variant 2.0 Micro Analysis Module ILLUMINA, INC. PFR 2023-06-15 00816270020149 TruSight™ Cystic Fibrosis Library Preparation ILLUMINA, INC. PFR 2020-04-09