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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2009-11-30 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2021-01-29 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2012-05-22 |
| High Throughput Dna Sequence Analyzer | PFF | Class 2 | Immunology | No | 2014-09-17 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2009-11-30 |
| Dna Genetic Analyzer | PCA | Class 2 | Clinical Chemistry | No | 2013-03-13 |
| Thermocycler, Generic | OUL | Class 1 | Clinical Chemistry | No | 2011-05-24 |
| Reagents For Molecular Diagnostic Test Systems | PFT | Class 1 | Clinical Chemistry | No | 2014-09-17 |
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 TorrentDx Sample Dilution Kit
Ion TorrentDx 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)