Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009875001

FEI Number

3009875001

Entity Name

Vela Operations Singapore Pte Ltd

City/State/Country

Singapore Central Singapore, SG

Establishment Address

50 Science Park Road, #05-07, The Kendall, Singapore Central Singapore 117406, SG

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Vela Operations Singapore Pte Ltd (Owner Number: 10041832)

Owner / Operator Contact Address

50 Science Park Road, #05-07, Singapore, SG-01 117406, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 SQ HIV Genotyping Assay Sentosa ST Template Kit Sentosa SX IA Template Prep Kit Sentosa SQ 318 Chip Kit Sentosa SQ Sequencing Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OQO	Herpes Simplex Virus Nucleic Acid Amplification Assay	Microbiology	Class 2	866.3305	2019-01-20
PFF	High Throughput Dna Sequence Analyzer	Immunology	Class 2	862.2265	2014-10-21
QIC	Hiv-1 Genotyping Assay Using Ngs Technology	Medical Genetics	Class 2	866.3955	2024-06-15
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2012-09-07
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2016-08-11
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-04-28
QIC	Hiv-1 Genotyping Assay Using Ngs Technology	Medical Genetics	Class 2	866.3955	2020-06-10
PFT	Reagents For Molecular Diagnostic Test Systems	Clinical Chemistry	Class 1	862.3800	2017-07-24

Official Correspondent

Boon King Teh

US Agent Details

Keisha Shaut Business: Vela Diagnostics Email: keisha.shaut@veladx.com Phone: (973) 3695549

Related Public Records

Same Entity

Vela Operations Singapore Pte Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

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2023365	DiaSorin Molecular LLC	CYPRESS, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009875001. Last updated year: 2026. Please use registration number 3009875001 when referencing this establishment in official correspondence.