FDA Registration
Active
🇸🇬 Singapore
Vela Operations Singapore Pte Ltd
Reg #: 3009875001
·
FEI: 3009875001
·
Expires 2026
Products
8
Proprietary Names
22
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- Vela Operations Singapore Pte Ltd
- Registration Number
- 3009875001
- FEI Number
- 3009875001
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 50 Science Park Road, #05-07, The Kendall
- City
- Singapore Central Singapore
- Country
- SG
Regulatory Submissions
- 510(k) Number
- K172509
Owner / Operator
- Firm Name
- Vela Operations Singapore Pte Ltd
- Operator Number
- 10041832
- Address
- 50 Science Park Road, #05-07
- City
- Singapore
- State
- Central Singapore
- Postal Code
- 117406
- Country
- SG
- Correspondent
- Boon King Teh
US Agent
- Business Name
- Vela Diagnostics
- Contact Name
- Keisha Shaut
- Address
- 353c Us Highway 46 Ste 250
- City
- Fairfield
- State
- NJ
- ZIP
- 07004
- Country
- US
- [email protected]
- Phone
- 973 3695549
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Herpes Simplex Virus Nucleic Acid Amplification Assay | OQO | Class 2 | Microbiology | No | 2019-01-20 |
| High Throughput Dna Sequence Analyzer | PFF | Class 2 | Immunology | No | 2014-10-21 |
| Hiv-1 Genotyping Assay Using Ngs Technology | QIC | Class 2 | Medical Genetics | No | 2024-06-15 |
| Station, Pipetting And Diluting, For Clinical Use | JQW | Class 1 | Clinical Chemistry | No | 2012-09-07 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2016-08-11 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-04-28 |
| Reagents For Molecular Diagnostic Test Systems | PFT | Class 1 | Clinical Chemistry | No | 2017-07-24 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2017-12-13 |
Proprietary Names
Sentosa SA201 HSV 1/2 Qualitative PC Test
Sentosa ST401e
Sentosa ST401i
Sentosa SQ301 Server and Sentosa SQ Suite Software
Sentosa SQ Reporter Software
Sentosa SQ301 Sequencer
Sentosa SQ HIV Genotyping Assay
Sentosa SX101
ViroKey HT Virus Total Nucleic Acid Kit
Sentosa SX Virus Total Nucleic Acid Kit v2
Sentosa SX Virus Total Nucleic Acid Plus Kit
ViroKey SX Virus Total Nucleic Acid Kit
ViroKey SARS-CoV-2 RT- PCR Test
ViroKey SARS-CoV-2 RT- PCR Test v2
Sentosa ST Template Kit
Sentosa SX IA Template Prep Kit
Sentosa SQ 318 Chip Kit
Sentosa SQ Sequencing Kit
Sentosa SA201 Real-Time PCR Instrument
SA201 Reporter Assay Package
SA201 Reporter
SA201 Series Software
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device