Identity
- Trade Name
- MiSeq™Dx Instrument EUDAMEDMiSeqDx Instrument FDA UDI
- Generic Name
- Nucleic acid sequence analyser IVD, next-generation sequencing (NGS) FDA UDI
- Device Name
- MiSeq™Dx Instrument EUDAMEDThe Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. FDA UDI
- Model / Reference
- DX-410-1001 EUDAMED15036706 FDA UDI
- Description
- The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. FDA UDI
Identifiers
- Catalog Number
- DX-410-1001 FDA UDI
- Primary DI / UDI-DI
- 00816270020002 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081627002MISEQQP EUDAMED
- 510(k) Number
- DEN130011 FDA UDI
- FDA Product Code
- PFF FDA UDI
- EMDN Code
- W02050115 DNA SYNTHESIZERS EUDAMED
- GMDN Term
- Nucleic acid sequence analyser IVD, next-generation sequencing (NGS) FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2265 FDA UDI
- 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
Yes
EUDAMED
New Device
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MiSeq™Dx Instrument by Illumina, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0081627002MISEQQP | 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 6108282e-0e5c-40dc-bb5f-5bcef770a6aa 61 fields · synced Jun 18, 2026
- FDA UDI 56bf0a34-1169-46e4-8e8f-0d091ab854fb 35 fields · synced May 30, 2026