No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10190302017336 | A51222 | OOI | real time Nucleic acid amplification system | 2 | Applied Biosystems | ||
2 | 10190302000840 | 6431 | PFF | High throughput DNA sequence analyzer | 2 | Ion PGM™ Dx Chip Minifuge | ||
3 | 10190302005937 | 4405182 | PCA | DNA genetic analyzer | 2 | 3500 Dx Genetic Analyzer | ||
4 | 10190302016162 | A51197 | OOI | real time Nucleic acid amplification system | 2 | QuantStudio™ 7 Pro Dx 96-Well Heated Cover | ||
5 | 10190302000710 | 4478552 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Spectral Calibration Plate with Cy®5 Dye | ||
6 | 10190302000512 | 9911 | OUL | Thermocycler, generic | 1 | Veriti™ Dx 96-Well Fast Thermal Cycler | ||
7 | 10190302000420 | 4432632 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Spectral Calibration Plate with TAMRA™ Dye | ||
8 | 10190302000390 | 4432614 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Spectral Calibration Plate with ROX™ Dye | ||
9 | 10190302000222 | 7503 | NSU | Instrumentation for clinical multiplex test systems | 2 | 7500 Fast Dx Real-Time PCR Instrument | ||
10 | 10190302015592 | A47324 | OOI | real time Nucleic acid amplification system | 2 | Applied Biosystems™ QuantStudio™ 5 Dx Real-Time PCR System | ||
11 | 10190302000673 | 4462113 | PCA | DNA genetic analyzer | Sequencing Standard v1.1, 3500 Dx Series | |||
12 | 10190302000383 | 4432607 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Spectral Calibration Plate with VIC™ Dye | ||
13 | 10190302000369 | 4432593 | OOI | real time Nucleic acid amplification system | 2 | RNase P 96-Well Instrument Verification Plate | ||
14 | 10190302007399 | 4452205 | VIIA 7 DX ARRAY CARD BUCKET | OUL | Thermocycler, generic | 1 | Array Card Clip | |
15 | 10190302000659 | 3500xLDxCS2 | PCA | DNA genetic analyzer | 2 | 3500 xL Dx CS2 Genetic Analyzer 24-capillary | ||
16 | 10190302000598 | 7821 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Block | ||
17 | 10190302016940 | A52439 | OOI | real time Nucleic acid amplification system | 2 | 384-Well Spectral Calibration Plate 1 | ||
18 | 10190302017329 | A51220 | OOI | real time Nucleic acid amplification system | 2 | Applied Biosystems | ||
19 | 10190302016148 | A50745 | OOI | real time Nucleic acid amplification system | 2 | QuantStudio™ 7 Pro Dx Real-Time PCR System | ||
20 | 10190302000765 | 4481308 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Background Calibration Plate | ||
21 | 10190302003353 | A31909 | OOI | real time Nucleic acid amplification system | 2 | 96-Well 0.2-mL Calibration Plate 3 (TAMRA, NED, and Cy 5 dyes) | ||
22 | 10190302000529 | 9912 | OUL | Thermocycler, generic | 1 | Veriti™ Dx 96-Well Thermal Cycler | ||
23 | 10190302000468 | 4432656 | OOI | real time Nucleic acid amplification system | 2 | Rnase P Fast 96-Well Instrument Verification Plate | ||
24 | 10190302000413 | 4432626 | OOI | real time Nucleic acid amplification system | 2 | 96-Well Region of Interst and Background Plates | ||
25 | 10190302016964 | A52440 | OOI | real time Nucleic acid amplification system | 2 | 384-Well Spectral Calibration Plate 2 | ||
26 | 10190302016155 | A51195 | OOI | real time Nucleic acid amplification system | 2 | QuantStudio™ 7 Pro Dx 96-Well Block | ||
27 | 10190302003124 | A31908 | OOI | real time Nucleic acid amplification system | 2 | 96-Well 0.2-mL Calibration Plate 2 (ABY, JUN, and MUSTANG PURPLE dyes) | ||
28 | 10190302000536 | 9913 | OUL | Thermocycler, generic | 1 | Veriti™ Dx 384-Well Thermal Cycler | ||
29 | 10190302000697 | 8788 | OOI | real time Nucleic acid amplification system | 2 | QuantStudioTM Dx Real-Time PCR Instrument | ||
30 | 10190302000642 | 3500DxCS2 | PCA | DNA genetic analyzer | 2 | 3500 Dx CS2 Genetic Analyzer 8-capillary | ||
31 | 10190302000611 | 7831 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Heater Cover | ||
32 | 10190302000505 | 4443774 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Normalization Plates with FAM™/ROX™ and VIC™/ROX™ Dyes | ||
33 | 10190302000437 | 4432638 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Region of Interest (ROI) and Background Plates | ||
34 | 10190302000321 | 4432500 | OOI | real time Nucleic acid amplification system | 2 | Rnase P Fast 384-Well Instrument Verification Plate | ||
35 | 10190302000314 | 4432482 | OOI | real time Nucleic acid amplification system | 2 | 384-Well Region of Interest and Background Plates | ||
36 | 10190302000864 | ONE TOUCH ES DX | PFF | High throughput DNA sequence analyzer | 2 | Ion One Touch™ ES Dx | ||
37 | 10190302015615 | A48389 | OOI | real time Nucleic acid amplification system | 2 | QuantStudio(TM) Dx Software Version 1.0.4 | ||
38 | 10190302005944 | 4405183 | PCA | DNA genetic analyzer | 2 | 3500xL Dx Genetic Analyzer | ||
39 | 10190302000734 | 4480914 | OOI | real time Nucleic acid amplification system | 2 | Lamp, Halogen RC, IVD | ||
40 | 10190302000857 | ONE TOUCH DX | PFF | High throughput DNA sequence analyzer | 2 | Ion One Touch™ Dx | ||
41 | 10190302001304 | A31907 | OOI | real time Nucleic acid amplification system | 2 | 96-Well 0.2-mL Calibration Plate 1 (FAM, VIC, ROX, and SYBR dyes) | ||
42 | 10190302006736 | 1.0.1 | OOI | real time Nucleic acid amplification system | 2 | QuantStudio Dx Emerging Pathogens Edition Software Version 1.0.1 | ||
43 | 10190302005654 | A33178 | PFF | High throughput DNA sequence analyzer | 2 | Torrent Suite™ Dx SW, V5.6.4 | ||
44 | 10190302000376 | 4432600 | OOI | real time Nucleic acid amplification system | 2 | Fast 96-Well Spectral Calibration Plate with FAM™ Dye |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00816270020699 | 20014053 | 20014053 | The Illumina MiSeqDx is intended for targeted sequencing of human DNA using Illu The Illumina MiSeqDx is intended for targeted sequencing of human DNA using Illumina sequencing consumables and libraries prepared from human genomic DNA extracted from peripheral whole blood or formalin-fixed, paraffin-embedded (FFPE) tissue. Libraries are prepared by amplifying targets and adding sample indexes and capture sequences. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases as they are incorporated into growing DNA strands. The Real-Time Analysis (RTA) software performs image analysis and base calling, and assigns a quality score to each base for each sequencing cycle.The MiSeqDx instrument is not intended for whole genome or de novo sequencing. The MiSeqDx instrument is to be used with registered and listed, cleared, or approved IVD reagents and analytical software. | MiSeq™ Dx (China) | ILLUMINA, INC. |
2 | 00816270020637 | 20068232 | 20068232 | The NovaSeq™ 6000Dx Instrument is intended for sequencing DNA libraries with in The NovaSeq™ 6000Dx Instrument is intended for sequencing DNA libraries with in vitro diagnostic assays. For its input, the NovaSeq™ 6000Dx uses libraries generated from DNA where sample indexes and capture sequences are added to amplified targets. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect fluorescently labeled single nucleotide bases as they are incorporated into growing DNA strands. The Real-Time Analysis (RTA) software performs image analysis and base calling and assigns a quality score to each base for each sequencing cycle. When primary analysis finishes, secondary analysis can be executed on the included and required Illumina DRAGEN Server for NovaSeq™ 6000Dx to process base calls. The NovaSeq™ 6000Dx uses different secondary analysis applications depending on the workflow. | NovaSeq™ 6000Dx | ILLUMINA, INC. |
3 | 00816270020125 | 20005715 | 20005715 | The Illumina NextSeq 550Dx instrument is intended for sequencing DNA libraries p The Illumina NextSeq 550Dx instrument is intended for sequencing DNA libraries prepared by adding sample indices and capture sequences to amplified targets. These libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases incorporated into growing DNA strands. Instrument software performs image analysis and base calling, assigning a quality score to each base for each sequencing cycle. When primary analysis finishes, secondary analysis processes base calls on the instrument. The NextSeq 550Dx instrument uses different secondary analysis modules depending on the workflow. For the germline or somatic variant calling modules, data processing includes de-multiplexing, FASTQ file generation, alignment, variant calling, and generation of variant call format (VCF) files containing information regarding variants found at specific positions in a reference genome. | NextSeq 550Dx Sequencing System | ILLUMINA, INC. |
4 | 00816270020002 | 15036706 | DX-410-1001 | The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signa The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through theuse of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysissoftware. | MiSeqDx Instrument | ILLUMINA, INC. |
5 | 10190302016810 | A46166 | Torrent Suite DX, Installer v5.12.5 | LIFE TECHNOLOGIES CORPORATION | ||
6 | 10190302014090 | A36601 | Torrent Suite DX, Installer v5.8 | LIFE TECHNOLOGIES CORPORATION | ||
7 | 10190302005654 | A33178 | Torrent Suite™ Dx SW, V5.6.4 | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. | ||
8 | 10190302000864 | ONE TOUCH ES DX | Ion One Touch™ ES Dx | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. | ||
9 | 10190302000857 | ONE TOUCH DX | Ion One Touch™ Dx | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. | ||
10 | 10190302000840 | 6431 | Ion PGM™ Dx Chip Minifuge | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. | ||
11 | 10190302000833 | 7469 | Personal Genome Machine™ Dx (PGM™) Dx | LIFE TECHNOLOGIES HOLDINGS PTE. LTD. | ||
12 | 08885013950076 | 400120 | 400120 | ST401e is used for enrichment and forms part of SQ301 Platform. | Sentosa ST401e | VELA OPERATIONS SINGAPORE PTE. LTD. |
13 | 08885013950069 | 400124 | 400124 | Sentosa ST401i is used for emulsion PCR and forms part of SQ301 Platform. | Sentosa ST401i | VELA OPERATIONS SINGAPORE PTE. LTD. |
14 | 08885013950045 | 7468 | 400103 | The Sentosa® SQ301 Platform is an in vitro diagnostic system composed of a seque The Sentosa® SQ301 Platform is an in vitro diagnostic system composed of a sequencing instrument that measures the hydrogen ions that are generated during the incorporation of nucleotides in the DNA sequencing reaction and the ancillary instrumentation necessary for sample processing. This platform is used in conjunction with instrument-specific library preparation kits, template kits, sequencing kits, chip kits and data analysis software. The Sentosa® SQ301 Platform is intended for targeted sequencing of various biological samples. The Sentosa® SQ301 Platform is not intended for whole genome or de novo sequencing. | Sentosa SQ301 Sequencer | VELA OPERATIONS SINGAPORE PTE. LTD. |