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Local Run Manager CF 139-Variant 2.0 Micro Analysis Module
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Local Run Manager CF 139-Variant 2.0 Micro Analysis Module FDA UDI
- Generic Name
- Cystic fibrosis IVD, kit, multiplex FDA UDI
- Device Name
- The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when processing 24–36 samples. 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 TruSight Cystic Fibrosis. For more information on TruSight Cystic Fibrosis. FDA UDI
- Model / Reference
- 20072975 FDA UDI
- Description
- The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when processing 24–36 samples. 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 TruSight Cystic Fibrosis. For more information on TruSight Cystic Fibrosis. FDA UDI
Identifiers
- Catalog Number
- 20072975 FDA UDI
- Primary DI / UDI-DI
- 00816270020378 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cystic fibrosis IVD, kit, multiplex
Local Run Manager CF 139-Variant 2.0 Micro 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 Clinical Sequencing Analysis Module — Illumina, Inc. · Class II
- Local Run Manager CF 139 Variant 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:
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 610932b9-9bce-431c-a311-da7d2922bbd1 36 fields · synced May 31, 2026