Identity
- Trade Name
- MiSeq™ Dx (China) FDA UDI
- Generic Name
- Nucleic acid sequence analyser IVD, next-generation sequencing (NGS) FDA UDI
- Device Name
- The Illumina MiSeqDx is intended for targeted sequencing of human DNA using Illumina sequencing consumables and libraries prepared from human genomic DNA extracted from peripheral whole blood or formalin-fixed, paraffin-embedded (FFPE) tissue. Libraries are prepared by amplifying targets and adding sample indexes and capture sequences. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases as they are incorporated into growing DNA strands. The Real-Time Analysis (RTA) software performs image analysis and base calling, and assigns a quality score to each base for each sequencing cycle. The MiSeqDx instrument is not intended for whole genome or de novo sequencing. The MiSeqDx instrument is to be used with registered and listed, cleared, or approved IVD reagents and analytical software. FDA UDI
- Model / Reference
- 20014053 FDA UDI
- Description
- The Illumina MiSeqDx is intended for targeted sequencing of human DNA using Illumina sequencing consumables and libraries prepared from human genomic DNA extracted from peripheral whole blood or formalin-fixed, paraffin-embedded (FFPE) tissue. Libraries are prepared by amplifying targets and adding sample indexes and capture sequences. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases as they are incorporated into growing DNA strands. The Real-Time Analysis (RTA) software performs image analysis and base calling, and assigns a quality score to each base for each sequencing cycle. The MiSeqDx instrument is not intended for whole genome or de novo sequencing. The MiSeqDx instrument is to be used with registered and listed, cleared, or approved IVD reagents and analytical software. FDA UDI
Identifiers
- Catalog Number
- 20014053 FDA UDI
- Primary DI / UDI-DI
- 00816270020699 FDA UDI
- FDA Product Code
- PFF FDA UDI
- GMDN Term
- Nucleic acid sequence analyser IVD, next-generation sequencing (NGS) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2265 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
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
Category: Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)
MiSeq™ Dx (China) by Illumina, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 05b3aea9-ac22-425c-88e5-e8608e66b8cc 34 fields · synced Jun 8, 2026