Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007102730

FEI Number

3007102730

Entity Name

Illumina Singapore Pte. Ltd.

City/State/Country

Singapore Central Singapore, SG

Establishment Address

29 Woodlands Industrial Park E1, Northtech, Singapore Central Singapore 757716, SG

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Illumina, Inc. (Owner Number: 10030352)

Owner / Operator Contact Address

5200 Illumina Way, San Diego, CA 92122, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 MiSeqDx Reagent Kit V3 Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (16 samples) MiSeqDx 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PFF	High Throughput Dna Sequence Analyzer	Immunology	Class 2	862.2265	2017-12-04
PFT	Reagents For Molecular Diagnostic Test Systems	Clinical Chemistry	Class 1	862.3800	2017-09-01

Official Correspondent

Karen Gutekunst

US Agent Details

Karen Gutekunst Business: ILLUMINA Email: kgutekunst@illumina.com Phone: (858) 2555541

Related Public Records

Same Entity

Illumina, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006296346	Illumina, Inc. Hayward	Hayward, CA, US
3003218906	Illumina, Inc.	San Diego, CA, US

Similar Registrations

Registration Number	Establishment Name	Location
3003335080	Life Technologies Corporation	FREDERICK, MD, US
3009207631	LIFE TECHNOLOGIES CORPORATION	Austin, TX, US
3009875001	Vela Operations Singapore Pte Ltd	Singapore Central Singapore, SG
3007287152	LIFE TECHNOLOGIES CORPORATION	Carlsbad, CA, US
3006296346	Illumina, Inc. Hayward	Hayward, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007102730. Last updated year: 2026. Please use registration number 3007102730 when referencing this establishment in official correspondence.