Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009207631

FEI Number

3009207631

Entity Name

LIFE TECHNOLOGIES CORPORATION

City/State/Country

Austin, TX, US

Establishment Address

2130 Woodward St, Austin, TX 78744, US

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

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 TaqPath COVID-19, FluA, FluB Combo Kit TaqPath COVID-19 Combo Kit TaqPath COVID-19 High Throughput Combo Kit TaqPath COVID-19 Fast PCR Combo Kit 2 TaqPath COVID-19 RNase P Combo Kit 2 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 TaqPath qPCR Master Mix, CG Avidin/Biotin Blocking Kit TaqPath 1-Step Multiplex Master Mix TaqPath 1-Step Multiplex Master Mix No ROX Normal Rabbit Serum 10% Normal Goat Serum Streptavidin Lyophilized Streptavidin HRP ELISA Grade BigDye® Xterminator Purification Kit Streptavidin-HRP Conjugate TaqPath 1-Step RT-qPCR MM, CG Streptavidin R-PE Conjugate CAS-Block (Ready-to-use) TaqPath ProAmp Multiplex Master Mix TaqPath ProAmp Master Mix Normal Goat Serum TaqPath BactoPure Microbial Detection Master Mix, NO ROX, 1 x 5 mL TaqPath BactoPure Microbial Detection Master Mix, NO ROX, 1 x 50 mL TaqPath BactoPure Microbial Detection Master Mix, 1 x 1 mL TaqPath BactoPure Microbial Detection Master Mix, 1 x 50 mL Elution Solution 25mL TaqPath BactoPure Microbial Detection Master Mix, NO ROX, 1 x 1 mL TaqPath BactoPure Microbial Detection Master Mix, 1 x 5 mL TaqPath BactoPure Microbial Detection Master Mix, 5 x 1 mL TaqPath BactoPure Microbial Detection Master Mix, NO ROX, 5 x 1 mL TaqPath DuraPlex 1-Step RT-qPCR Master Mix Binding Beads 2mL TaqPath DuraPlex 1-Step RT- qPCR Master Mix (No ROX) Binding Solution 50mL Wash Buffer 200mL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PFF	High Throughput Dna Sequence Analyzer	Immunology	Class 2	862.2265	2014-09-17
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-03-30
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2017-06-26
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2007-08-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3009573214	Thermo Fisher Scientific Baltics UAB	Vilnius Vilniaus Miestas, LT
3003673482	Life Technologies Holdings Pte Ltd.	SINGAPORE North West, SG
3009976420	LIFE TECHNOLOGIES CORPORATION	Pleasanton, CA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

Similar Registrations

Registration Number	Establishment Name	Location
3003335080	Life Technologies Corporation	FREDERICK, MD, US
3009875001	Vela Operations Singapore Pte Ltd	Singapore Central Singapore, SG
3007287152	LIFE TECHNOLOGIES CORPORATION	Carlsbad, CA, US
3007102730	Illumina Singapore Pte. Ltd.	Singapore Central Singapore, SG
3006296346	Illumina, Inc. Hayward	Hayward, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009207631. Last updated year: 2026. Please use registration number 3009207631 when referencing this establishment in official correspondence.