Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009573214

FEI Number

3009573214

Entity Name

Thermo Fisher Scientific Baltics UAB

City/State/Country

Vilnius Vilniaus Miestas, LT

Establishment Address

V. A. Graiciuno G. 8, Vilnius Vilniaus Miestas 02241, LT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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 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 Dynabeads HLA Cell Prep II 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 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2017-06-26
JCF	Lymphocyte Separation Medium	Hematology	Class 1	864.8500	2000-12-20
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2007-08-24
PCA	Dna Genetic Analyzer	Clinical Chemistry	Class 2	862.2570	2013-03-13

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
3003673482	Life Technologies Holdings Pte Ltd.	SINGAPORE North West, SG
3009976420	LIFE TECHNOLOGIES CORPORATION	Pleasanton, CA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009573214. Last updated year: 2026. Please use registration number 3009573214 when referencing this establishment in official correspondence.