Data / Medical devices / Singapore / Vela Operations Singapore Pte Ltd
Vela Operations Singapore Pte Ltd: FDA-registered device maker in Singapore Central Singapore, Singapore, 1 510(k) clearance
Vela Operations Singapore Pte Ltd is registered with the FDA (registration 3009875001) in Singapore Central Singapore, Singapore. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 1, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009875001
- Address
- 50 Science Park Road #05-07, The Kendall, Singapore Central Singapore, Singapore, 117406
- Owner or operator
- Vela Operations Singapore Pte Ltd (10041832)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- September 7, 2012
- Registered through
- 2026
- Brand names listed
- SA201 Reporter, SA201 Reporter Assay Package, SA201 Series Software, Sentosa SA201 HSV 1/2 Qualitative PC Test, Sentosa SA201 Real-Time PCR Instrument, Sentosa SQ 318 Chip Kit, Sentosa SQ HIV Genotyping Assay, Sentosa SQ Reporter Software and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Sample Concentrator | JJH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Herpes Simplex Virus Nucleic Acid Amplification Assay | OQO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| High Throughput Dna Sequence Analyzer | PFF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Hiv-1 Genotyping Assay Using Ngs Technology | QIC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Reagents For Molecular Diagnostic Test Systems | PFT | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | N | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Station, Pipetting And Diluting, For Clinical Use | JQW | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 1, 2018 | K172509 | Sentosa SA201 HSV 1/2 Qualitative PCR Test | OQO | Substantially Equivalent | Vela Diagnostics USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Herpes Simplex Virus Nucleic Acid Amplification Assay
- All makers of Station, Pipetting And Diluting, For Clinical Use
- All makers of Clinical Sample Concentrator
- All makers of High Throughput Dna Sequence Analyzer
- All makers of Reagents For Molecular Diagnostic Test Systems
Updated February 1, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.