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Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx
EUDAMEDFDA UDIClass A (EU MDR)
Ref 20063022
Identity
- Trade Name
- Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx EUDAMEDLocal Run Manager DNA GenerateFASTQ Dx Module for MiSeq™Dx FDA UDI
- Generic Name
- Nucleic acid sequencing reagent kit IVD FDA UDI
- Device Name
- IDPEDx software module and applications EUDAMEDThe Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for MiSeq™Dx is used for sequencing run setup, run monitoring, and primary analysis on the MiSeq™Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay. The LRM software (SW) includes the UDI information in the User Interface. FDA UDI
- Model / Reference
- 20063022 EUDAMEDFDA UDI
- Description
- The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for MiSeq™Dx is used for sequencing run setup, run monitoring, and primary analysis on the MiSeq™Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay. The LRM software (SW) includes the UDI information in the User Interface. FDA UDI
Identifiers
- Catalog Number
- 20063022 FDA UDI
- Primary DI / UDI-DI
- 00816270020392 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081627002IDPESWRF EUDAMED
- FDA Product Code
- PFT FDA UDI
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
- GMDN Term
- Nucleic acid sequencing reagent kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3800 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx by Illumina, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0081627002IDPESWRF | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Illumina, Inc.
- EUDAMED SRN
- US-MF-000013476
- Authorised Representative
- Illumina Netherlands B.V. NL-AR-000012614
Sources (2)
- EUDAMED b8725a38-567a-4314-8252-7248b55ff73c 61 fields · synced Jul 14, 2026
- FDA UDI 2561ad48-789a-4e1c-9a87-5330c9906910 35 fields · synced May 29, 2026