FDA Registration
Active
🇸🇬 Singapore
Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (96 samples)
Reg #: 3007102730
·
FEI: 3007102730
·
Expires 2025
Products
1
Proprietary Names
20
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Illumina Singapore Pte. Ltd.
- Registration Number
- 3007102730
- FEI Number
- 3007102730
- Status
- Active
- Expiry Year
- 2025
- 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
- [email protected]
- Phone
- 858 2555541
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagents For Molecular Diagnostic Test Systems | PFT | Class 1 | Clinical Chemistry | No | 2017-09-01 |
Proprietary Names
Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (96 samples)
TruSeq Custom Amplicon Kit Dx- FFPE
TruSight Cystic Fibrosis Library Prep
NovaSeq 6000Dx Library Tube, 24 pack
Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (16 samples)
NovaSeq 6000Dx S4 Buffer Cartridge
Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (96 samples)
NovaSeq 6000Dx S4 Reagent v1.5 Kit (300 cycles)
Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq 550Dx
NovaSeq 6000Dx S2 Reagent v1.5 Kit (300 cycles)
NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles)
MiSeqDx Reagent Kit V3
NovaSeq 6000Dx Library Tube
Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx
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 B (16 samples)
TruSeq Custom Amplicon Kit Dx
DRAGEN for Illumina DNA Prep with Enrichment Dx Application for NovaSeq 6000Dx
NovaSeq 6000Dx S2 Buffer Cartridge
Establishment Types
Manufacture Medical Device