MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run) DX-102-1003

GUDID 00816270020033

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 (20 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15035471 MiSeqDx Cystic Fibrosis 139 Variant Assay 1/5 15038252, MiSeqDx Cystic Fibrosis 139 Variant Assay 1A; 15038253, MiSeqDx Cystic Fibrosis 139 Variant Assay 1B; 15035478, MiSeqDx Cystic Fibrosis 139 Variant Assay 2/5; 15035472, MiSeqDx Cystic Fibrosis 139 Variant Assay 3/5; 15038254, MiSeqDx Cystic Fibrosis 139 Variant Assay 3A; 15038255, MiSeqDx Cystic Fibrosis 139 Variant Assay 3B; 15036624, MiSeqDx Cystic Fibrosis 139 Variant Assay 4/5; 15038119, MiSeqDx Cystic Fibrosis 139 Variant Assay 5/5.

ILLUMINA, INC.

Cystic fibrosis IVD, kit, multiplex
Primary Device ID00816270020033
NIH Device Record Keya450e111-06f1-4c60-ace2-71cc57c8e1ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run)
Version Model Number15036577
Catalog NumberDX-102-1003
Company DUNS033305264
Company NameILLUMINA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816270020033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-14

Devices Manufactured by ILLUMINA, INC.

00816270020262 - Local Run Manager CF Clinical Sequencing Analysis Module2023-07-13 The Local Run Manager CF Clinical Sequencing analysis module is for use with Illumina MiSeqDx Cystic Fibrosis Clinical Sequencin
00816270020286 - Local Run Manager CF 139 Variant Analysis Module2023-07-13 The Local Run Manager CF 139 Variant analysis module is for use with Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay. The ass
00816270020378 - Local Run Manager CF 139-Variant 2.0 Micro Analysis Module2023-07-13 The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when p
00816270020385 - Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module2023-07-13 The Local Run Manager CF Clinical Seq 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis Clinical Sequencing Ass
00816270020392 - Local Run Manager DNA GenerateFASTQ Dx Module for MiSeq™Dx2022-11-15 The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for MiSeq™Dx is used for sequencing run setup, run monitoring, and pri
00816270020415 - Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx2022-11-15 The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx is used for sequencing run setup, run monitoring, a
00816270020743 - DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx2022-11-15 The DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx application is used for sequencing run setup, ru
00816270020453 - Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples)2022-10-28 The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumables used to prepare sample libraries from periph

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