This page includes the latest FDA filings for Vela Operations Singapore Pte L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3009071564 |
| FEI Number | 3009071564 |
| Name | Vela Operations USA, Inc. |
| Owner & Operator | Vela Operations Singapore Pte Ltd |
| Contact Address | 50 Science Park Road #05-07 Singapore SG-01 Central Singapore 117406 SG |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2441 South 3850 West Salt Lake City, UT 84120 US |
| Establishment Type |
|
| Registration Number | 3009875001 |
| FEI Number | 3009875001 |
| Name | Vela Operations Singapore Pte Ltd |
| Owner & Operator | Vela Operations Singapore Pte Ltd |
| Contact Address | 50 Science Park Road #05-07 Singapore SG-01 Central Singapore 117406 SG |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 50 Science Park Road #05-07, The Kendall Singapore Central Singapore, 117406 SG |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| VELA OPERATIONS SINGAPORE PTE. LTD. | ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (4x96) | 2022-03-07 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (8x48) | 2022-03-07 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | ViroKey® HT Virus Total Nucleic Acid Kit (4x96) 301088 | 2022-03-02 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SQ HIV-1 Positive Control Kit (8) 300800 | 2021-01-27 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SQ HIV-1 Positive Control Kit (96) 300729 | 2021-01-27 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SX IA Solution Kit (8) 300735 | 2021-01-27 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SX IA Reagents Kit (8) 300734 | 2021-01-27 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SX IA Reactions Kit (4) 300733 | 2021-01-27 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SQ Sequencing Solutions (8) 300316 | 2021-01-27 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SQ Sequencing Reagents (8) 300313 | 2021-01-27 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SQ Sequencing Supplies (8) 300306 | 2021-01-27 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa ST Template Beads (8) 300322 | 2021-01-27 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa ST Template Solutions (8) 300325 | 2021-01-27 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa ST Template Reagents (8) 300319 | 2021-01-27 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa ST Template Supplies (8) 300328 | 2021-01-27 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SQ Virus Testing Solutions (4x24) 300732 | 2021-01-26 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SQ HIV-1 Genotyping Reagents (4x24) 300731 | 2021-01-26 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SX101 400089 | 2021-01-26 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | ViroKey™ SX Virus Total Nucleic Acid Kit 300677 | 2020-07-07 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SA201 HSV-1/2 PCR Test 300216 | 2020-07-07 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) 300395 | 2020-05-21 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) 300353 | 2020-05-21 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SQ 318 Chip Kit (8) 300300 | 2020-05-21 |
| VELA OPERATIONS SINGAPORE PTE. LTD. | Sentosa SA201 Real-Time PCR Instrument 400125 | 2020-05-21 |
Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd] | Vela? Shiga Toxin Direct Test | 2019-06-05 |
Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd] | Vela? Staph ID/R Blood Culture Panel | 2019-06-05 |
Vela Operations Singapore Pte Ltd | Sentosa SA201 HSV 1/2 PCR Test | 2019-01-20 |
Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd] | Great Basin Bordetella Direct Test | 2019-01-09 |
Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd] | Great Basin Bordetella Direct Test | 2019-01-09 |
Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd] | Vela Operations US Stool Bacterial Pathogens Panel (SBPP) | 2018-11-14 |
Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd] | Vela Operations US Stool Bacterial Pathogens Panel (SBPP) | 2018-11-14 |
Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd] | Great Basin Group B Streptococcus (GBS) Assay | 2018-11-14 |
Vela Operations USA, Inc. [Vela Operations Singapore Pte Ltd] | Great Basin Group B Streptococcus (GBS) Assay | 2018-11-14 |
Vela Operations Singapore Pte Ltd | Sentosa SA201 Real-Time PCR Instrument; SA201 Series Software; SA201 Reporter; SA201 Reporter Assay Package | 2017-12-13 |
Vela Operations Singapore Pte Ltd | Sentosa ST Template Kit | 2017-07-24 |
Vela Operations Singapore Pte Ltd | Sentosa SQ Sequencing Kit | 2017-07-24 |
Vela Operations Singapore Pte Ltd | Sentosa SQ 318 Chip Kit | 2017-07-24 |
Vela Operations Singapore Pte Ltd | Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) | 2016-08-11 |
Vela Operations Singapore Pte Ltd | Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) | 2016-08-11 |
Vela Operations Singapore Pte Ltd | Sentosa ST401i | 2014-10-21 |
Vela Operations Singapore Pte Ltd | Sentosa ST401e | 2014-10-21 |
Vela Operations Singapore Pte Ltd | Sentosa SQ301 Server and Sentosa SQ Suite Software | 2014-10-21 |
Vela Operations Singapore Pte Ltd | Sentosa SQ301 Sequencer | 2014-10-21 |
Vela Operations Singapore Pte Ltd | Sentosa SQ Reporter Software | 2014-10-21 |
Vela Operations Singapore Pte Ltd | Sentosa SX 101 | 2012-09-07 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020090133662 | Singapore,Singapore -> Los Angeles, California | BOX AND INNER TRAY HS CODE: 48192000 INCOTERMS: DDP FREIGHT PREPAID ORIGINAL B L SURRENDERED CFS CFS | 3 PKG |
| 2020083135296 | Singapore,Singapore -> Los Angeles, California | BOX AND INNER TRAY HS CODE: 48192000 INCOTERMS: DDP FREIGHT PREPAID ORIGINAL B L SURRENDERED CFS CFS | 3 PKG |
| 2019110522741 | Singapore,Singapore -> New York/Newark Area, Newark, New Jersey | SENTOSA SQ301 SERVER | 8 CTN |
| 2018103038665 | Singapore,Singapore -> Los Angeles, California | SENTOSA SQ301 SERVER T620 SENTOSA SQ REPORT PERPETUAL (SER+LIC) HS CODE : 84715010 . SENTOSA ST401T HS CODE: 84198919 HS CODE: 841330 | 2 PKG |