Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003673482

FEI Number

3003673482

Entity Name

Life Technologies Holdings Pte Ltd.

City/State/Country

SINGAPORE North West, SG

Establishment Address

BLK 33, MARSILING INDUSTRIAL, ESTATE ROAD 3, No. 07-06, SINGAPORE North West 739256, SG

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Life Technologies Corporation (Owner Number: 9915045)

Owner / Operator Contact Address

5781 Van Allen Way, --, Carlsbad, CA 92008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2009-11-30
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2021-01-29
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2012-05-22
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2012-05-22
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2013-03-18
PFF	High Throughput Dna Sequence Analyzer	Immunology	Class 2	862.2265	2014-09-17
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2009-11-30
PCA	Dna Genetic Analyzer	Clinical Chemistry	Class 2	862.2570	2013-03-13
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2017-06-26
OUL	Thermocycler, Generic	Clinical Chemistry	Class 1	862.2310	2011-05-24

Official Correspondent

No official correspondent registered.

US Agent Details

Jody Schulz Email: Jody.Schulz@thermofisher.com Phone: (414) 5344809

Related Public Records

Same Entity

Life Technologies Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1317268	Life Technologies Corporation	GRAND ISLAND, NY, US
3015529000	LIFE TECHNOLOGIES CORPORATION	Guilford, CT, US
3009207631	LIFE TECHNOLOGIES CORPORATION	Austin, TX, US
3009573214	Thermo Fisher Scientific Baltics UAB	Vilnius Vilniaus Miestas, LT
3009976420	LIFE TECHNOLOGIES CORPORATION	Pleasanton, CA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003673482. Last updated year: 2026. Please use registration number 3003673482 when referencing this establishment in official correspondence.