FDA Registration Active 🇸🇬 Singapore

Illumina Singapore Pte. Ltd.

Reg #: 3007102730 · FEI: 3007102730 · Expires 2026
Products
2
Proprietary Names
23
Establishment Types
1
Classifications
2

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Registration Details

Registration Name
Illumina Singapore Pte. Ltd.
Registration Number
3007102730
FEI Number
3007102730
Status
Active
Expiry Year
2026
Initial Importer
No
Address
29 Woodlands Industrial Park E1, Northtech
City
Singapore Central Singapore
Country
SG

Owner / Operator

Firm Name
Illumina, Inc.
Operator Number
10030352
Address
5200 Illumina Way
City
San Diego
State
CA
Postal Code
92122
Country
US
Correspondent
Karen Gutekunst

US Agent

Business Name
ILLUMINA
Contact Name
Karen Gutekunst
Address
5200 Illumina Way
City
San Diego
State
CA
ZIP
92122
Country
US
Phone
858 2555541

Products

Device Name Product Code
High Throughput Dna Sequence Analyzer PFF
Reagents For Molecular Diagnostic Test Systems PFT

Proprietary Names

NextSeq™ 550Dx Instrument NovaSeq™ 6000Dx Instrument Illumina DRAGEN Server for NextSeq 550Dx NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles) DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NovaSeq 6000Dx Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (16 samples) TruSeq™ Custom Amplicon Kit Dx- FFPE NovaSeq™ 6000Dx S2 Buffer Cartridge NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (96 samples) TruSight™ Cystic Fibrosis Library Prep NovaSeq™ 6000Dx Library Tube, 24 pack NovaSeq™ 6000Dx Library Tube MiSeq™Dx Reagent Kit V3 Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (16 samples) MiSeq™Dx Reagent Kit V3 Micro NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (96 samples) TruSeq™ Custom Amplicon Kit Dx NovaSeq™ 6000Dx S4 Buffer Cartridge DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx

Establishment Types

Manufacture Medical Device