FDA Registration Active 🇸🇬 Singapore

Life Technologies Holdings Pte Ltd.

Reg #: 3003673482 · FEI: 3003673482 · Expires 2026
Products
8
Proprietary Names
180
Establishment Types
2
Classifications
8

Registration Details

Registration Name
Life Technologies Holdings Pte Ltd.
Registration Number
3003673482
FEI Number
3003673482
Status
Active
Expiry Year
2026
Initial Importer
No
Address
BLK 33, MARSILING INDUSTRIAL, ESTATE ROAD 3, No. 07-06
City
SINGAPORE North West
Country
SG

Regulatory Submissions

510(k) Number
K082562

Owner / Operator

Firm Name
Life Technologies Corporation
Operator Number
9915045
Address
5781 Van Allen Way, --
City
Carlsbad
State
CA
Postal Code
92008
Country
US

Products

Device Name Product Code
Instrumentation For Clinical Multiplex Test Systems NSU
Real Time Nucleic Acid Amplification System OOI
Clinical Sample Concentrator JJH
High Throughput Dna Sequence Analyzer PFF
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Dna Genetic Analyzer PCA
Thermocycler, Generic OUL
Reagents For Molecular Diagnostic Test Systems PFT

Proprietary Names

ASSY,INSTRUMENT 7500 FAST DX 384-Well Spectral Calibration Plate 2 (ABY™, JUN™, MUSTANG PURPLE™, NEO™, Cy®5 Dyes) RNase P 384-Well Instrument Verification Plate Diomini™ Software 384-Well Spectral Calibration Plate 1 (FAM™, VIC™, ROX™, SYBR™, TAMRA™ Dyes) QuantStudio™ 5 Dx Software 384-Well Spectral Calibration plate with TAMRA Dye 96-Well Spectral Calibration Plate with Alexa Fluor 647 Dye Quantstudio™ 7 Pro Dx 384-Well Heated Cover Applied Biosystems™ QuantStudio™ 5 Dx Real-Time PCR Instrument (96 Well 0.2mL Block) Quantstudio Dx 384-Well CE-IVD 96-Well 0.2-mL Calibration Plate 2 (ABY, JUN, and MUSTANG PURPLE dyes) 96-Well 0.2-mL Spectral Calibration Plate 1 (FAM, VIC, ROX, and SYBR Dyes) QuantStudio™ 7 Pro Dx 96-Well Heated Cover QuantStudio™ 7 Pro Dx Real-Time PCR Instrument 384-Well Normalization plates with FAM/ROX and VIC/ROX Dyes Quantstudio™ 7 Pro Dx 384-Well Block QuantStudio™ 7 Pro Dx 96-Well Block QuantStudio™ 7 Pro Dx Software 384-Well Region of Interest (ROI) and Background Plates 384-Well Background Calibration Plate Fast 96-Well Spectral Calibration Plate with Alexa Fluor 647 Dye 384-Well 10-Dye Calibration Kit Standard 96-well 10-Dye Calibration Kit Rnase P Fast 384-Well Instrument Verification Plate 384-Well Spectral Calibration plate with FAM Dye 96-Well 0.2-mL Calibration Plate 3 (TAMRA, NED, and Cy 5 dyes) RNase P 96-Well Instrument Verification Plate 384-Well Spectral Calibration plate with VIC Dye 96-Well Region of Interest (ROI) and Background Plates FAST 96-Well Region of Interest (ROI) and Background Plates 384 Well Spectral Calibration plate with ROX Dye CLINICAL SAMPLE CONCENTRATOR REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM Lamp, Halogen RC, IVD Rnase P Fast 96-Well Instrument Verification Plate Fast 96Well Region of Interest & Background Plates FAM/ROX/VIC/ROXDye Fast 96-Well Background Calibration Plate QuantStudio Dx Software V1.3 Fast 96Well Spectral Calibration Plate w/ VIC Dye Fast 96Well Spectral Calibration Plate w/FAM Dye Fast 96-Well Spectral Calibration Plate w/ Cy5 Dye Fast 96-Well Block Fast 96-Well Heater Cover VIIA 7 DX FAST 96-WELL PLATE ADAPTOR QuantStudioTM Dx Real-Time PCR Instrument Fast 96Well NormalizationPlates Kit; QuantStudio Dx Software Version 1.4 Fast 96Well Spectral Calibration Plate w/TAMRA Dye QuantStudio SW V1.1 KIT Fast 96Well Spectral Calibration Plate w/ROX Dye Genexus™ Dx SW 6.8.2.1 Ion One Touch™ ES Dx Ion One Touch™ Dx Ion PGM™ Dx Chip Minifuge Torrent Suite™ Dx SW Personal Genome Machine™ Dx (PGM™) Dx Torrent Suite™ DX SW, Installer v5.12.5 Sentosa® SQ Suite Software Genexus™ Dx Cartridge Genexus™ Dx Bottle 1 and 3 Torrent Suite™ DX SW, Installer V5.14.2 Torrent Suite™ Dx SW v5.6.4 Genexus™ Dx Pipette Tips Genexus Dx Conical Bottles Genexus™ Dx Barcodes 1-32 HD Genexus™ Dx Strip 2-HD Genexus Dx Filter Genexus™ Dx Strip 4 Genexus™ Dx SW 6.8.2 Torrent Suite™ DX SW, Installer V5.14 Torrent Suite™ Dx SW v5.8 Installer Genexus™ Dx Strip 1 Genexus™ Dx Bottle 2 Genexus™ Dx Strip 3-GX5 Genexus™ Dx Integrated Sequencer Genexus™ Dx GX5 Chip and Genexus Coupler KingFisher Presto with 96 DW HEAD GPLE KingFisher APEX, 96 COMBI 384 W Plate BC GPLE MicroAmp Adhesive Film Applicator KingFisher Presto with 24 DW HEAD GPLE KingFisher APEX, 96 PCR MicroAmp® EnduraPlate™ Optical 96-Well Fast GPLE, 20 plates KingFisher Flex with 96KF HEAD GPLE KingFisher Flex with 24 DW HEAD GPLE KingFisher Flex WITH 96 PCR HEAD GPLE MicroAmp® EnduraPlate™ Optical 96-Well GPLE, 20 plates MicroAmp™ Optical 96-Well Reaction Plate with Barcode KingFisher APEX, 24 COMBI MicroAmp™ Optical 96-Well Reaction Plate MicroAmp™ Optical Fast 96-Well Reaction Plate with Barcode KingFisher APEX, 96 DW OPTICAL ADHESIVE COVERS GPLE MicroAmp® EnduraPlate™ Optical 96-Well GPLE, 500 plates MicroAmp™ Optical Fast 96-Well Reaction Plate MicroAmp® EnduraPlate™ Optical 384-Well GPLE, 20 plates KingFisher Flex with 96 DW HEAD GPLE MicroAmp™ Optical 384-Well Reaction Plate with Barcode SeqStudio™ 8 Flex Dx Genetic Analyzer 3500 Dx Series 96-Well Standard Retainer & Base Set Hi-Di™ Formamide 3500 Dx Series POP-6™ (384) Performance Optimized Polymer 3500 Dx Series 3500 Dx Series Septa 96-Well POP-7™ (384) Performance Optimized Polymer 3500 Dx Series 3500xL Dx Capillary Array 50 cm Conditioning Reagent 3500 Dx Series 3500 Dx Series Data Collection Software 3 IVD v3.2 3500xL Dx Genetic Analyzer 3500 Dx Series Septa Cathode Buffer Container POP-6™ (960) Performance Optimized Polymer 3500 Dx Series 3500 Dx Genetic Analyzer Sequencing Standard v1.1 3500 Dx Series 3500 Dx Series Polymer Pouch Caps GeneScan™ 600 LIZ™ Size Standard v2 - Dx 3500 Dx Capillary Array 50 cm Anode Buffer Container 3500 Dx Series 3500 Dx Series 96-Well Fast (0.1mL) Retainer & Base Set DS-30 Matrix Standard Kit (Dye Set D) - Dx Pump Cleaning Kit 3500 Dx Series DS-33 Matrix Standard (Dye Set G5) - Dx Cathode Buffer Container 3500 Dx Series POP-7™ (960) Performance Optimized Polymer 3500 Dx Series Sequencing Standard BigDyeTM Terminator V1.1-Dx SeqStudio™ 24 Flex Dx Genetic Analyzer Genexus Dx Purification System Genexus Dx Purification Supplies 2 Ion Torrent™ Dx DNA Quantification Kit Ion Torrent™ Dx RNA Quantification Kit Ion Torrent™Dx Sample Dilution Kit Ion Torrent™Dx Total NA Isolation Kit (RT) Ion Torrent™ Dx Total NA Isolation Kit (-20 C) Ion Torrent™ Dx cDNA Synthesis Kit KingFisher™ Apex Dx Purification Instrument MagMAX™ Dx Viral/Pathogen NA Isolation Kit MagMAX™ Viral/Pathogen II (MVP II) Nucleic Acid Isolation Kit Genexus Dx FFPE DNA and RNA Purification Genexus Dx Nucleic Acid Quantitation Veriti™ Dx 384-Well Thermal Cycler Veriti™ Dx 96-Well Fast Thermal Cycler VeritiPro™ Dx Thermal Cycler Veriti™ Dx 96-Well Thermal Cycler Polymer Delivery Pump Cleaning Kit Dx POP-7™ Polymer Dx (960 Samples) Cathode Buffer Container Dx POP-7™ Polymer Dx (384 Samples) GeneScan™ 600 LIZ™ Size Standard v2 Dx SeqStudio™ Flex Dx series 96-Well Fast (0.1-mL) Retainer & Base Set Ion OneTouch™ Dx Template Reagents Ion PGM™ Dx Library Equalizer Ion OneTouch™ Dx Template Supplies Ion OneTouch™ Dx Sequencing Reagents Ion OneTouch™ Dx Template Solutions Ion OneTouch™ Dx Sequencing Solutions DS-33 Matrix Standard (Dye Set G5) Dx Ion PGM™ Dx Sequencing Supplies Anode Buffer Container Dx Polymer Pouch Caps, Dx Sequencing Standard BigDye™ Terminator v1.1 Dx DS-30 Matrix Standard Kit (Dye Set D) Dx POP-6™ Polymer Dx (384 Samples) Sequencing Standard BigDye™ Terminator v3.1 Dx DS-33 GeneScan™ Install Kit Dx with GeneScan™ 600 LIZ™ v2 Ion PGM™ 318 Dx Chip Kit SeqStudio™ Flex Dx series 96-Well Standard Retainer & Base Set DynaMag™ 16-2mL Tube Dx Ion PGM™ Dx Library Reagents 3500 Dx Capillary Array 50-cm POP-6™ Polymer Dx (960 Samples) DynaMag™ 96-Well Plate Dx, 5-200 uL Ion OneTouch™ Dx Template ES Beads Septa Cathode Buffer Container Dx SeqStudio™ 8 Flex Dx Capillary Array 50 cm SeqStudio™ 24 Flex Dx Capillary Array 50 cm Conditioning Reagent Dx CBC Wash Septa Clip Dx 3500xL Dx Capillary Array 50-cm Hi-Di™ Formamide Dx (5 mL) 96-Well Septa Dx

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)