Local Run Manager CF 139 Variant Analysis Module

FDA UDI

Class II (US FDA UDI)

by Illumina, Inc.

Identity

Trade Name: Local Run Manager CF 139 Variant Analysis Module FDA UDI
Generic Name: Cystic fibrosis IVD, kit, multiplex FDA UDI
Device Name: The Local Run Manager CF 139 Variant analysis module is for use with Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay. The assay detects 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The analysis module performs secondary analysis and report generation from sequencing runs that use the MiSeqDx Cystic Fibrosis 139-Variant Assay. FDA UDI
Model / Reference: 20047009 FDA UDI
Description: The Local Run Manager CF 139 Variant analysis module is for use with Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay. The assay detects 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The analysis module performs secondary analysis and report generation from sequencing runs that use the MiSeqDx Cystic Fibrosis 139-Variant Assay. FDA UDI

Identifiers

Catalog Number: 20047009 FDA UDI
Primary DI / UDI-DI: 00816270020286 FDA UDI
510(k) Number: K124006 FDA UDI
FDA Product Code: PFR FDA UDI
GMDN Term: Cystic fibrosis IVD, kit, multiplex FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cystic fibrosis IVD, kit, multiplex

Local Run Manager CF 139 Variant Analysis Module by Illumina, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cystic fibrosis IVD, kit, multiplex.

xTAG® Cystic Fibrosis (CFTR) 60 kit v2 — Luminex Molecular Diagnostics, Inc. · Class II
xTAG® Cystic Fibrosis (CFTR) 39 kit v2 — Luminex Molecular Diagnostics, Inc. · Class II
Local Run Manager CF 139-Variant 2.0 Micro Analysis Module — Illumina, Inc. · Class II
Local Run Manager CF Clinical Sequencing Analysis Module — Illumina, Inc. · Class II
Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module — Illumina, Inc. · Class II

Cleared under the same submission

K124006 also covers:

Local Run Manager CF 139-Variant 2.0 Micro Analysis Module — Illumina, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Illumina, Inc.

Sources (1)

FDA UDI c1fd62bd-dccc-42b8-9ad5-c1b2680fc36a 36 fields · synced Jun 8, 2026